Skip to main content

Kutner, J.S., Smith, M.C., Corbin, L. Hemphill, L., Benton, K., Mellis, B.K., . . . Fairclough, D.L. (2008). Massage therapy versus simple touch to improve pain and mood in patients with advanced cancer: A randomized trial. Annals of Internal Medicine, 149, 369–379.

Study Purpose

To test the hypothesis that massage would decrease pain and analgesic medicine use

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to a massage treatment group or to a control group in which patients received simple touch controlled for time and attention. Individual baseline data for disease characteristics, pain, symptom distress, quality of life, functional status, expectations from massage, and concurrent interventions were collected within 72 hours of study inclusion and at three weekly visits over the three to four weeks of study participation for measurement of sustained effects. Data collectors were blinded to study group assignment. Participants received up to three 30-minute treatments over two weeks, with at least 24 hours between treatment sessions, according to a schedule jointly determined by the patient and the treatment provider. Treatment providers obtained immediate outcome data prior to and following each treatment. All participants received routine care in addition to study interventions. Massage intervention included gentle effleurage, petrissage, and myofascial trigger point release. Most frequently massaged areas were neck and upper back, arms, hands, lower legs, and feet. Massages were performed by licensed massage therapists who had at least six months’ experience working with patients with advanced cancer. Control touch included placement of both hands on the participant bilaterally on the neck, shoulder blades, lower back, calves, heels, clavicles, lower arms, hands, patellae, and feet with light and consistent pressure. All treatment providers had standardized hands-on training and were evaluated for competency.

Sample Characteristics

  • The study had 348 participants.
  • Mean participant age was 65.2 ±14.4 in the experimental group and 64.2 ±14.4 in the control group.
  • The sample was 61% female and 39% male.
  • The most common diagnoses were breast and lung cancers; 100% had metastatic disease, and 27% had bone metastasis.
  • Fifty-four percent had constant pain, and 26% of participants’ pain was neuropathic.
  • Forty-four percent were married or in a committed relationship, 39%–42% had a college education level or higher, and 86% were non-Hispanic white.
  • In the experimental group, 77% were receiving care at home; in the control group, 81% were receiving care at home.
  • Mean worst pain in 24 hours in both groups was 6.4 or greater at baseline.

Setting

  • Multisite
  • Other setting
  • 15 U.S. hospices and the University of Colorado Cancer Center

Phase of Care and Clinical Applications

  • End-of-life care phase
  • End of life and palliative care

Study Design

A randomized, single-blind, controlled trial design was used.

Measurement Instruments/Methods

  • Memorial Pain Assessment Card (MPAC): 0–10 point scale for immediate effect
  • Brief Pain Inventory (BPI): For sustained measure
  • MPAC Mood Scale
  • McGill Quality of Life Questionnaire
  • Memorial Symptom Assessment Scale (MSAS)
  • Recording of name, dose, and frequency of medication for symptom management

Results

Both massage and touch were associated with significant improvements in immediate and sustained pain outcomes. Massage was superior to touch, but the difference was not statistically significant. Both groups demonstrated statistical, but not clinically significant, improvement in BPI scores. Both massage and simple touch were reported to be associated with statistically significant immediate improvement in mood, with massage showing statistically superior effect compared to touch. Confidence intervals were provided but significance levels were not reported. Both groups demonstrated improvement in physical and emotional symptom distress and quality of life across weekly evaluations, but there were no differences between groups. There were no adverse effects associated with the interventions, and no differences in general adverse events or mortality between groups. Differences in pain medication use were not reported.

Conclusions

Both massage and simple touch appeared to have immediate beneficial effects on pain and mood in these patients. Both groups experienced slight improvement in pain, quality of life, and symptom distress over time. These changes were minimal, showing statistical significance but not clinical relevance.

Limitations

  • Findings are limited to patients with very advanced cancer, the majority of whom were in hospice programs, and may not be applicable to other patient groups.
  • There was no usual care control group. Having an appropriate attentional control group was useful, but given the findings that both study groups experienced benefits, the attention itself may be the most relevant factor in changes seen.

Nursing Implications

Simple touch appeared to have a short-term positive effect on patient mood and pain experience. This is an intervention that should be easy to provide for patients, and could be something that caregivers could also be educated to provide. This intervention could be useful for intermittent use as an adjunct to other interventions for pain management. Formal massage did not provide significantly greater effects. Given findings of simple touch in the population studied here, evaluation of this approach in other patient groups can be useful.

Print

Kus, T., Aktas, G., Alpak, G., Kalender, M.E., Sevinc, A., Kul, S., . . . Camci, C. (2016). Efficacy of venlafaxine for the relief of taxane and oxaliplatin-induced acute neurotoxicity: A single-center retrospective case-control study. Supportive Care in Cancer, 24, 2085–2091. 

Study Purpose

To evaluate the effect of venlafaxine 75 mg daily oral administration on peripheral neuropathy (PN) pain severity reduction rates in patients on taxane- or oxaliplatin-based chemotherapy with moderate to severe painful chemotherapy-induced PN (CIPN) compared to participants who refused treatment

Intervention Characteristics/Basic Study Process

Venlafaxine XR 75 mg orally once daily (duration unspecified). Measurement time points were at baseline (before venlafaxine but after neurotoxic chemotherapy initiation) and every three weeks up to nine weeks. 
 
Retrospective chart analysis investigated patients prescribed venlafaxine for CIPN pain and mild depression compared to a case matched control group that had rejected CIPN treatment. All patients were on taxane-, taxane with carboplatin–, or oxaliplatin-based chemotherapy. The charts were first reviewed for participants with documented CIPN history (signs/symptoms). Then participants who had sensory CIPN severity of 1 or greater on the Common Criteria for Adverse Events (CTCAE), version 4.03, and 4 or more out of 10 based on a mean numeric rating scale (NRS) score calculated from responses on the Neuropathic Pain Symptom Inventory (NPSI) were selected. For patients who met these and the eligibility criteria listed below, CIPN severity (NPSI NRS mean score) and adverse events (CTCAE, version 4.03) were evaluated at three, six, and nine-week follow-ups.

Sample Characteristics

  • N = 199   
  • MEAN AGE = 52.78 years
  • MALES: 15.1%, FEMALES: 84.9%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Participants had diagnosed and patient-reported moderate to severe painful CIPN while on a taxane- (45.7% of participants), paclitaxel and carboplatin– (30.2%), or oxaliplatin-based regimens (24.1%). Most patients had breast, gynecologic, or colorectal cancer of any stage. Most individuals (68%) were either older than age 65 years or had diabetes.
  • OTHER KEY SAMPLE CHARACTERISTICS: All 91 patients in the treatment group had mild depression treated with oral venlafaxine 75 mg daily. Participants were eligible if they had no history of prior neurotoxic chemotherapy, motor CIPN, diabetic PN, alcohol dependence, neurological metastases, or unstable psychological condition. Patients were also excluded if they were taking psychotropic or analgesic medications, including opioids, gabapentin, pregabalin, and drugs that could influence serotonin levels. However, selected analgesics were allowed, such as acetaminophen, aspirin, and nonsteroidal anti-inflammatory drugs.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: University Hospital in Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

Retrospective, case-control, nonblinded design with a venlafaxine-treated group and a case-matched control group that had rejected CIPN treatment

Measurement Instruments/Methods

Every three weeks, PN was measured using the 10-item NPSI mean composite score, which ranged from 0 (“no pain”) to 10 (“worst pain imaginable”). Each NPSI item used the same 0–10 NRS to measure patient-reported severity for the past 24 hours of various neuropathic pain symptoms (e.g., burning pain, pain provoked by cold, abnormal pin-and-needle sensations). The severity of venlafaxine-associated adverse effects was also measured using the CTCAE, version 4.03, ranging from 0 (normal) to 4 (life-threatening).

Results

Painful and nonpainful PN symptoms (NPSI scores) significantly improved from baseline to the three-, six-, and nine-week follow-ups for participants on venlafaxine (p < 0.001), but did not change over the nine-week study period for participants not on venlafaxine. A higher percentage of participants in the venlafaxine arm compared to the control experienced at least a 75% reduction in pin-and-needle sensations at each follow-up (p < 0.001). A similar trend was found for symptoms of pain provoked by cold. In subgroup analysis, a higher percentage of participants with grade 1 CIPN at baseline (CTCAE, version 4.03) displayed at least a 75% reduction in PN severity than participants with grade 2 CIPN (p = 0.031). Grade 1–2 nausea/vomiting, asthenia/somnolence, dizziness, and insomnia were experienced by no more than three participants, and no participants experienced grade 3–4 adverse effects from venlafaxine.

Conclusions

This study provided weak evidence supporting the superiority of venlafaxine compared to no venlafaxine in decreasing PN symptoms among participants with moderate to severe painful CIPN and mild depression while receiving taxane- and/or platinum-based chemotherapy. Participants who received venlafaxine 75 mg once daily experienced a reduction in painful and nonpainful PN symptoms after three weeks that continued through nine weeks, compared to no change in participants who did not receive venlafaxine. Participants with milder PN before treatment experienced the most benefit. However, these results may not be reliable or valid because of the retrospective design and potentially biased study procedures/methods/analysis.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Questionable protocol fidelity
  • No report or control for potential confounding factors, such as chemotherapy factors, cancer stage, smoking, supplementation with neuroprotectants or vitamins, vitamin B deficiency, peripheral arterial disease, and diabetes (without PN)
  • It was unclear at what time participants initiated venlafaxine in relation to their chemotherapy treatment, and whether all participants received chemotherapy throughout the entire study or if some had already completed treatment; therefore, differing cumulative doses of chemotherapy and maturation effects could have biased the results.
  • Although the article reported, “Baseline demographic and clinical characteristics were distributed in the two groups (Table 1),” no chi square p values were reported comparing baseline cancer type and chemotherapy regimen between the two groups.
  • Although prior evidence supports the validity/reliability of non-English versions of the NPSI sum score in patients with other neuropathic pain conditions, no evidence was cited to support its validity/reliability as a mean score and among English-speaking participants with painful CIPN.
  • No discussion of who extracted data from the charts
  • Effect size was not reported, and the authors' analysis methods (two-way repeated measure ANOVA) may not have been appropriate to evaluate between- and within-group differences in two independent groups. Rather, a mixed model may have been more appropriate.
 

 

Nursing Implications

Additional testing of venlafaxine in large prospective, randomized, controlled trials is needed before it can be used in clinical practice to treat CIPN. However, the positive results of this trial emphasize the importance of continual nursing assessment of PN signs and symptoms throughout chemotherapy because pain treatments may be most beneficial to patients with acute mild CIPN.

Print

Kusuki, S., Hashii, Y., Yoshida, H., Takizawa, S., Sato, E., Tokimasa, S., . . . Ozono, K. (2009). Antifungal prophylaxis with micafungin in patients treated for childhood cancer. Pediatric Blood and Cancer, 53, 605–609.

Study Purpose

The primary aim of this study was to determine if micafungin is an effective and safe antifungal prophylaxis to be used for neutropenic pediatric patients undergoing chemotherapy treatment or stem cell transplantation treatment for cancer.  

Intervention Characteristics/Basic Study Process

Patient records were reviewed for pediatric oncology patients who received micafungin via IV (3 mg/kg per day) while they were neutropenic from May 2006 to September 2008. A total of 40 children were included in a record review that encompassed 146 patient cycles of chemotherapy.

Sample Characteristics

  • The sample consisted of 40 patients.
  • Ages ranged from 1–17 years old.
  • Key disease characteristics included acute leukemia, non-Hodgkin lymphoma, and solid tumors.
  • Although 40 patients were treated prophylactically with micafungin, 39 of them received chemotherapy or stem cell transplantation for their disease. One did not receive either chemotherapy or stem cell transplantation as treatment for their cancer.
     

Setting

A single-site setting.

Phase of Care and Clinical Applications

  • The phase of care was active treatment
  • The application was pediatrics
     

Study Design

 Retrospective

Measurement Instruments/Methods

Development of probable, proven, or suspected invasive fungal infection.

Results

Of the 40 records reviewed, a total of 131 patient cycles were noted for chemotherapy and 15 patient cycles for those undergoing stem cell transplantation. Thirty of 40 patients had successful prevention of invasive fungal infection. Only one patient developed a diagnosed fungal infection, the rest of the failures were suspected fungal infections.

Conclusions

Based on this study, it appears that micafungin may be a safe and effective prophylactic treatment for fungal infection in pediatric patients with cancer. A larger randomized study would be beneficial to prove the success rates in a larger randomized group.

Limitations

  •  The study had a small sample size (less than 100).
  •  Invasive fungal infections are more prominent in hematologic malignancies as opposed to solid tumors, thus combining these two populations in a study may skew the results for positive benefit.
     

Nursing Implications

Micafungin is generally tolerated well with minor side effects and minimal drug-to-drug interactions as opposed to other treatment for fungal prophylaxis. More exclusive, randomized studies are needed to determine if it is appropriate for all patient populations and demographics.

Print

Kusagaya, H., Inui, N., Karayama, M., Fujisawa, T., Enomoto, N., Kuroishi, S., . . . Suda, T. (2015). Evaluation of palonosetron and dexamethasone with or without aprepitant to prevent carboplatin-induced nausea and vomiting in patients with advanced non-small-cell lung cancer. Lung Cancer, 90, 410–416. 

Study Purpose

To compare the efficacy of triplet versus doublet antiemetic prophylaxis in patients receiving carboplatin-based chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomized to triple drug or doublet prophylaxis. Both groups received palonosetron 0.75 mg on day 1 and dexamethasone 8 mg on days 1–3. In addition, those randomized to triple drug therapy received aprepitant 125 mg on day 1 and 80 mg on days 2–3.  Physicians recorded the use of rescue therapy.

Sample Characteristics

  • N = 80
  • KEY SAMPLE CHARACTERISTICS: Patients were chemotherapy naive.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Open-label, randomized, two-group trial

Measurement Instruments/Methods

Complete response rate was defined as no vomiting or rescue therapy.

Results

Aprepitant and control groups showed overall complete response rates of 80.5% and 76.9%, respectively. No significant difference existed between groups. No differences existed in patient reports of nausea.

Conclusions

Doublet antiemetic prophylaxis using palonosetron was as effective as triplet antiemetic treatment for the control of chemotherapy-induced nausea and vomiting (CINV).

Limitations

  • Measurement/methods not well described
  • Method of measurement of nausea was not described.  
  • Nausea apparently was not considered in the definition of complete control.

Nursing Implications

The finding suggest that antiemetics with a 5-HT3 and dexamethasone were as effective as triplet therapy, including an NK1, for control of CINV in patients receiving carboplatin. The 5-HT3 used here was palonosetron. A variety of mixed evidence exists regarding the comparative efficacy of doublet versus triplet antiemetics for CINV, as well as the comparative efficacy of dexamethasone-paring regimens and olanzapine-based regimens. Ongoing research and evaluation of comparative effectiveness for various chemotherapy regimens are needed. Multiple factors need to be considered in individualization of antiemetic treatments, and nurses need to evaluate the effectiveness of interventions across cycles to provide the most effective regimen for each patient.

Print

Kurzrock, R., Cortes, J., Thomas, D.A., Jeha, S., Pilat, S., & Talpaz, M. (2001). Pilot study of low-dose interleukin-11 in patients with bone marrow failure. Journal of Clinical Oncology, 19, 4165–4172.

Intervention Characteristics/Basic Study Process

  • Interleukin-11 (IL-11) 10 mcg/kg subcutaneous was given daily for two weeks followed by a two-week rest period, then dosing was repeated. After the first two courses (eight weeks), patients who responded continued maintenance therapy with which length of course, rest period, and doses were individualized based on response and side effects. Maintain platelet 150–450.
  • Platelet count equation = x 109 /L
  • During therapy, CBC with differential and reticulocyte count was done three times per week for the first six weeks and then at least weekly.
  • Patients were not transfused if platelets were greater than 10.
  • Patient responses had to last at least four weeks while on therapy.
  • Median baseline platelet = 12
     

Sample Characteristics

  • N = 16
  • AGE = 5–84 years 
  • MALES: 14, FEMALES: 4
  • Two patients were registered in error.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with myelodysplastic syndromes (MDS), aplastic anemia, graft failure, postchemotherapy aplasia, refractory anemia, bone marrow failure after autologous bone marrow transplant. No chemotherapy for two months or disease progression (other than worsening MDS) with platelets less than or equal to 50



 

Measurement Instruments/Methods

  • Raise platelet count without significant toxicity.
  • Response was doubling of platelets if baseline was 20–50 or tripling if baseline was less than or equal to 20.
  • Baseline = median of three untransfused counts within two weeks before starting therapy
     

Results

Six of 16 patients (38%) showed an increase in platelet count greater than 70K, mostly within the first two-week course. Of the six responders, their baseline platelet count was 1–48; none received transfusions. One patient also received granulocyte colony-stimulating factor and erythropoietin; time to response was approximately 20 weeks. Two patients had an abrupt decrease in platelet counts in the two-week rest period between courses. Response duration was 12–30 weeks. Side effects were mild peripheral edema (two patients treated with furosemide 20 mg PO), conjunctival infection, and myalgia; seven patients had no side effects.
 

Limitations

  • Small study size (16)
  • Six case studies' responders presented
  • Subset of patients with bone marrow failure, mild thrombocytopenia
  • Pilot study with review of existing literature
  • No control
  • Not randomized
     
Print

Kurosaka, S., Satoh, T., Chow, E., Asano, Y., Tabata, K., Kimura, M., . . . Baba, S. (2012). EORTC QLQ-BM22 and QLQ-C30 quality of life scores in patients with painful bone metastases of prostate cancer treated with strontium-89 radionuclide therapy. Annals of Nuclear Medicine, 26, 485–491.

Study Purpose

To evaluate the effect of Sr-89 radionuclide therapy on the quality of life of patients with prostate cancer with painful bone metastases

Intervention Characteristics/Basic Study Process

Sr-89 radionuclide therapy is an established alternative for the palliation of bone pain in prostate cancer. This study is to assess the Sr-89 radionuclide therapy on quality of life (QOL) in patients with prostate cancer and painful bone metastasis.

Sample Characteristics

  • N = 13
  • AGE = Unknown
  • MALES: 100%        
  • KEY DISEASE CHARACTERISTICS: Prostate cancer with bone metastases
  • OTHER KEY SAMPLE CHARACTERISTICS: Painful bone metastases

Setting

  • SITE: Single-site 
  • SETTING TYPE: Not specified 
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late-effects and survivorship
  • APPLICATIONS: Palliative care

Study Design

12-week, prospective, single-arm, open-label study

Measurement Instruments/Methods

  • Japanese version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-BM22 and -C30) scale
  • Visual Analog Scale (VAS)/Faces Pain Scale (FPS)
  • Prostate-specific antigen (PSA) test
  • Alkaline phosphate (ALP) test

Results

Three patients reduced their analgesic dosages within three months after Sr-89 treatment. No patients increased their analgesics dosages during the study period. According to the ECOG scale, performance status prior to the Sr-89 treatment was reported by the physician to be 0 or 1 in three patients (23.1%) and 2 or greater in the remaining 10 patients (76.9%). In the QLQ-C30, the mean score for global QOL was 29.9. Overall, there were no significant changes in patients' serum PSA and ALP after Se-89 therapy.

Conclusions

Using the EORTC QLQ-BM22 module, this study showed that Sr-89 therapy improves the comprehensive quality of life of patients with prostate cancer with bone metastases pain. This radionuclide therapy can provide not only reduced pain but also better psychosocial aspects and functional interference in this patient population.

Limitations

  • Small sample (< 30)
  • Key sample group differences that could influence results
  • Other limitations/explanation: Follow-up period after SR-89 intervention was short (three months). Efficacy if repeated-dose administration were given and the durable effect of Sr-89 were not evaluated.

Nursing Implications

Treatment with Sr-89 for prostate cancer with painful bone metastases could assist in pain management for this group of patients.

Print

Kurita, G.P., Benthien, K.S., Nordly, M., Mercadante, S., Klepstad, P., Sjogren, P., & European Palliative Care Research Collaborative (EPCRC). (2015). The evidence of neuraxial administration of analgesics for cancer-related pain: A systematic review. Acta Anaesthesiologica Scandinavica, 59, 1103–1115. 

Purpose

STUDY PURPOSE: To review the evidence for the intraspinal administration of analgesics for refractory cancer-related pain

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, EMBASE and Cochrane collaboration
 
KEYWORDS: Cancer, pain, epidural, intrathecal, subarachnoid, spinal, neuraxial, and no terms associated with acute pain
 
INCLUSION CRITERIA: Randomized, controlled trials investigating long-term epidural and/or subarachnoid analgesia in adults in the setting of systemic opioid treatment failure written in English.
 
EXCLUSION CRITERIA: Postoperative pain management, sample less than 20 patients, samples with mixed populations, no separation of results for cancer, and experimental studies

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 2,672

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A four-point quality scoring system was described.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 9
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not provided
  • SAMPLE RANGE ACROSS STUDIES: Not provided
  • KEY SAMPLE CHARACTERISTICS: Not provided

Phase of Care and Clinical Applications

PHASE OF CARE: End of life care
 
APPLICATIONS: Palliative care

Results

Four studies compared combinations of opioids and adjuvant drugs to opioids alone. Two studies compared a neuraxial drug bolus with a continuous infusion, one study compared a single drug with a placebo, and two studies compared neuraxial drug administration with comprehensive medical management. Pain relief was reported in all studies comparing opioids alone or in combination with adjuvant drugs. Better analgesic effects were reported with continuous infusion compared to bolus infusion. Sample sizes were small, and the quality of the studies was low.

Conclusions

There was limited evidence regarding neuraxial analgesic administration for intractable pain in patients with cancer.

Limitations

There were multiple methodologic concerns regarding study design and sample size. There were few studies for each type of study reviewed. Quality issues identified included loss to follow-up, unclear descriptions of setting, and no report of a power calculation. This review did not report sample sizes and graded items such as lack of setting description alone as equivalent to design issues.

Nursing Implications

There was limited evidence regarding the efficacy of intrathecal analgesic administration compared to other aggressive forms of pain control for patients with refractory pain, and the most effective drugs or drug combinations for this mode of delivery were not clear. Neuraxial treatment requires appropriate resources for safe administration and patient observation. Nurses have an important role to play regarding the selection of patients for safe home-based care delivery and the assessment of patient risks. Additional research comparing the efficacy of various aggressive pain management interventions is needed.

Print

Kurdi, M.S., & Muthukalai, S.P. (2016). The efficacy of oral melatonin in improving sleep in cancer patients with insomnia: A randomized double-blind placebo-controlled study. Indian Journal of Palliative Care, 22, 295–300. 

Study Purpose

To conduct a randomized, double-blind, placebo-controlled efficacy study evaluating the effects of oral melatonin in improving sleep in patients with cancer experiencing symptoms of insomnia

Intervention Characteristics/Basic Study Process

The investigators randomized participants who consented into group A (melatonin) or group B (placebo) using a fishbowl technique. Melatonin (3 mg) or placebo (multivitamin tablet) was provided by a pharmacist. Tablets were similar in color (light yellow) and shape, and were wrapped in similar envelopes and given to participants. Instructions were to take tablets two hours prior to bedtime every day for 14 days. The Athens Insomnia Scale (AIS) was given by phone or in person on days 1, 7, and 14. Patients and evaluators were blinded to the drug group, and the group was revealed to research staff at the end of the study. Results were compared using a paired t test.

Sample Characteristics

  • N = 50    
  • MALES: 13% (group A), 13% (group B); FEMALES: 12% (group A),12% (group B)
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Any patients with cancer with sleep complaints were included. No specific exclusion criteria were noted.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care

Study Design

Prospective, randomized, double-blind, placebo-controlled study

Measurement Instruments/Methods

The AIS self-assessment psychometric tool for measurement of sleep difficulty is an eight-item scale, and the first five items assess sleep induction, nighttime awakenings, final awakening, total sleep duration, and sleep quality. The remaining three items assess daytime well-being, functional capacity, and sleepiness. Items are scaled using 0–3 ratings, from 0 (no problem) to 3 (no sleep at all). The scale cut-off is 10 to predict outcomes.

Results

Power for a sample size of 25 was verified (90% and alpha = 5%). No significant differences in demographic characteristics of age and sex existed (p > 0.05). Each group had one dropout. The sample was predominantly stage 1 (44% [group A], 40% [group B]) and stage 2 (32% [group A], 36% [group B]), and stage 3–4 was 24% in each group. The majority of subjects (54%) had head and neck cancer (e.g., tongue, larynx) followed by cervix cancer (12%), and 14% had ovarian, gastrointestinal, breast, and sarcomas. Group A had significantly improvements in sleep (p < 0.05) on the AIS at week 1 with intragroup improvements in group A in week 2 (p = 0.00001). The percent change in sleep improvement within group A was significant (p = 0.0001) but not significant in group B (p > 0.05).

Conclusions

The use of 3 mg of melatonin two hours prior to bedtime is an effective nonpharmacological treatment for increasing sleep induction and sleep quality in patients with cancer experiencing insomnia.

Limitations

  • Small sample (< 100)
  • Measurement validity/reliability questionable
  • Questionable protocol fidelity

Nursing Implications

Additional large-scale randomized studies are needed to determine efficacy. Melatonin has emerging data to support the nonpharmacological treatment of sleep problems in patients with cancer.

Print

Kundel, Y., Nasser, N.J., Purim, O., Yerushalmi, R., Fenig, E., Pfeffer, R.M., . . . Brenner, B. (2013). Phase II study of concurrent capecitabine and external beam radiotherapy for pain control of bone metastases of breast cancer origin. PloS One, 8, e68327. 

Study Purpose

To test the safety and efficacy of treatment with localized radiotherapy and capecitabine for management of painful bone metastases

Intervention Characteristics/Basic Study Process

Women with bone metastases from breast cancer received radiation with 30Gy in 10 fractions to cover all metastatic bone regions, given 5 days per week.  Oral capecitabine at 1400mg/m2 was given 5 days per week, concurrently with radiation therapy.  Patients were evaluated weekly during treatment and for every 4 weeks after treatment, for a total of 12 weeks after completion of treatment.

Sample Characteristics

  • N = 29  
  • MEDIAN AGE = 59 years (range = 35–84 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All patients had one to three areas of bone metastases from breast cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Eleven patients were also on bisphosphonates.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Israel

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late-effects and survivorship
  • APPLICATIONS: Palliative care 

Study Design

Phase-II, observational study

Measurement Instruments/Methods

  • National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI's CTCEA) version 3
  • Pain intensity evaluated on four-point scale 
  • Side effects graded on 0–4 scale
  • Analgesic consumption graded on a five-point World Health Organization (WHO) scale
  • Response graded according to International Bone Metastases Consensus grading

Results

Side effects were mild. The most prevalent were nausea (33%), diarrhea (24%), weakness (21%), and mucositis (10%). The mean pain score decreased from 2.93 to 2.28 after one week (p < .002), to 1.45 after two weeks (p < .0001), and to 1.14 after four weeks (p < .01). Changes in pain scores after four weeks were not significant. Declines in analgesic use were noted during the first four weeks of treatment (p < .02) and were stabilized thereafter. The response rate was 31% at one week and 38% at 12 weeks. There were no differences between patients who did and did not receive bisphosphonates.

Conclusions

Combined radiation therapy with capecitabine was effective for the short-term reduction on pain from bone metastases with relatively mild side effects in the majority of subjects.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: No information was provided regarding pain medications used or pain duration.

Nursing Implications

Combined radiation therapy and capecitabine may be a promising intervention for the palliation of painful bone metastases. Further research is needed to fully determine its efficacy and toxicity.

Print

Kumar, S., Juresic, E., Barton, M., & Shafiq, J. (2010). Management of skin toxicity during radiation therapy: a review of the evidence. Journal of Medical Imaging and Radiation Oncology, 54, 264–279.

Purpose

To review the evidence for skin care management and conduct a survey to assess current practices in Australia and New Zealand.

Search Strategy

Databases searched were MEDLINE, PubMed, CINAHL, Google Scholar, and Google search. Searches were also completed by hand for the time period of 1980 to 2008.

Search keywords were radiation dermatitis, skin reaction, management, skin care, skin toxicity, moist desquamation, dry desquamation, erythema, sorbolene aqueous cream, and aloe vera.

Inclusion and exclusion criteria were not specified.

Literature Evaluated

Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.

Sample Characteristics

  • The final number of studies included was 31.
  • The sample size across studies was 3,174 participants (range 413–506).
  • Participants had various tumor types.
  • All participants received radiation therapy (RT).

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Results

Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity. Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects.

Conclusions

Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.

Limitations

  • Analysis was limited by combining all types of interventions together, which did not allow for differentiation between those agents individually shown to be effective and not effective.
  • Methods for evaluation of the quality of the research were not well described or incorporated into the analysis. 
  • Findings regarding management were questionable because of high heterogeneity among studies included in the meta-analysis. 
  • Actual odds ratios or effect sizes from the meta-analysis were not reported. 
  • Final recommendations stated by the authors were not consistent with the rest of the conclusions stated elsewhere in the article. 
  • The basis for recommendations, concerning evaluation of the quality of the evidence, was not clear. 
  • The authors stated that they weighted studies by sample size, but this method was not described.

Nursing Implications

Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.

Print
Subscribe to