To assess the efficacy and safety of lubiprostone in the treatment of patients with chronic constipation.

Patients had a washout period, followed by a two-week prerandomization period. Patients were randomized to receive either oral lubiprostone 24-mcg capsules (n = 119) or placebo (n = 118) twice daily with food and at least 8 oz of water. Patients were instructed to keep daily diaries to record their medication administration, use of medication rescues, and occurrences of bowel movements (BMs) (date and time). Study assessments were scheduled after one week (office visits), two weeks (telephone evaluation), four weeks (end-of-treatment office visit), and two weeks following the end of treatment.

• The study reported on a sample of 237 patients who met the Rome II criteria for functional constipation.
• Mean patient age was 46.2 years (SD = 12.13) for the lubiprostone group and 45.4 years (SD = 13.24) for the placebo group.
• The study comprised 104 women and 15 men in the lubiprostone group, and 105 women and 13 men in the placebo group.
• Constipation severity was 3 (SD = 0.82) in the lubiprostone group and 3 (SD = 0.76) in the placebo group. 
• Stool consistency was 2.7 (SD = 0.83) in the lubiprostone group and 2.8 (SD = 0.77) in the placebo group.
• All were normal patients with constipation.

• Multi-site
• United States

This was a randomized, double-blinded, placebo-controlled study.

• Daily BM diary
• Five-point scale of stool consistency
• Five-point scale of stool straining

• Lubiprostone was an effective treatment for chronic constipation, with more than 60% of patients having a spontaneous BM within 24 hours of their first dose.
• Patients taking lubiprostone also experienced significant improvement in spontaneous BM frequency, stool consistency, straining, severity, and abdominal bloating.
• Patients' global treatment effectiveness was significantly higher in the lubiprostone group compared with the placebo group.
• Fewer patients receiving lubiprostone required rescue medication.
• Nausea was the most common adverse side effect reported, occurring in 25 patients in the lubiprostone group compared to five patients in the placebo group.

Lubiprostone was an effective treatment for chronic constipation.

• The sample comprised more women than men.
• Nausea was reported as toxicity to the drug, but also was reported in the placebo group. In addition, nausea may also be seen in patients who have issues with constipation.
• The sample did not include patients specifically with cancer or related opioid-induced constipation. Therefore, applicability to that population is unclear.

Lubiprostone has been shown to be effective in the management of chronic constipation and is used for patients with chronic constipation related to irritable bowel syndrome. However, additional studies are warranted in patients with cancer, as well as the palliative care population, in which patients are receiving chemotherapy agents, antiemetics, and narcotics that contribute to their constipation.

To assess the effect of active manuka honey on the grade and duration of mucositis

Patients were randomly allocated by a computer-generated list of random numbers to be given active manuka honey or placebo (golden syrup) mixed with 2% sodium alginate, which increased the contact time by ensuring that the substance adhered sufficiently to the oral and oropharyngeal mucosa. They were shown the technique and given verbal and written instructions to rinse the mouth with 20 ml of the allocated substance and to swallow it slowly, 4 times per day for the duration of the radiotherapy (4 weeks) and for 2 weeks after treatment (42 days in total). To assess compliance, they were also asked to record daily on a card when they took the substance.

The patients were all to receive 4 weeks (20 fractions) of accelerated radiotherapy at a dose between 50 and 55 Gy. Synchronous or induction chemotherapy, or both, was permitted.

Since both substances in the study are known to be cariogenic in patients being treated by radiotherapy, all patients were seen by the hospital dentist before beginning treatment and were provided with fluoride toothpaste and a soft toothbrush and given written and verbal dental hygiene instructions. 

Inter-rater reliability was measured between assessors and found to be higher using the modified scale.

Weekly assessments of mucositis were undertaken during radiotherapy (four weeks) and every two weeks thereafter until the mucositis resolved. Weight was assessed at each assessment.

Swabs were taken from the throat to assess for bacterial and fungal infections. These were taken at baseline and during and after radiotherapy, and the process was overseen by a microbiologist consultant.

• The sample consisted of 131 patients, with 64 in the experimental arm and 63 in the control arm.
• The experimental arm was 83% male and 17% female. The control arm was 92% male and 8% female. 
• The mean age patients in the experimental arm was 59 years old. The mean age of patients in the control arm was 58 years.
• Patients were drawn from a consecutive sample who had either oral or oropharyngeal cancer.

Patients were recruited from an outpatient clinic at a cancer center in northwest England.

Patients were undergoing the active treatment phase of care.

This was a double-blind, randomized, controlled study. The treatment allocation was by minimization with an allocation probability of 2/3 to the arm that would yield a lower imbalance score.

A modified acute radiation toxicity scale of mucositis by the Radiation Therapy Oncology Group was used.

Primary analysis revealed no significant differences in the incidence of grade 3 mucositis or severity or duration of mucositis between the two groups. 

Ninety-eight percent of the patients managed at least 1 week of the intervention, and 67 patients managed more than 2 weeks. Median compliance was 2 weeks for both groups.

The incidence of pathogenic bacteria in both arms was similar to reported baseline values, which indicated that the levels of bacterial colonization were similar to those of an unirradiated mouth. It also confirms the previous findings that honey has a bacteriostatic effect, which might be the result of its hyperosmolar properties, as golden syrup had a similar effect.

No significant differences were found in either the primary or the secondary outcome measures when honey was compared with placebo. The results of the study did not agree with the findings of other trials.

• Poor compliance affected the potential impact of the intervention. Patients reported problems with the taste and texture of the product and cited the effort required to take them as reason for discontinuation.
• Compliance might have been hampered by the use of the carrier agent (sodium alginate).
• The intervention required too much volume and was too sweet for the subjects to be expected to use it daily.
• A different formulation of honey should be used for future studies, using only the active ingredient and using a more liquid formulation.
• This was a single institution study.
• No measurement for or discussion of the use of opioids for pain control in the results and discussion segment of the report, even though this topic was listed as a secondary outcome.
• The article was poorly written with several grammatical errors that hampered understanding.
• The authors did not specify if chemotherapy was given, and, if so, which drugs, amounts, and durations, all of which can influence the development of mucositis.
• Further research is needed to determine methods that are successful in treating grade 3-4 mucositis during radiotherapy.
• The study was not very practical if the median compliance was only half of the study treatment duration. The patients were to swallow 20 ml of honey 4 times a day for the duration of the study, which was too difficult for the participants to accomplish. This intervention is unlikely to be used in clinical practice.

Well-documented bacteriostatic properties of honey exist; further research needs to be done to determine feasibility in the realm of preventing oral mucositis.

To evaluate the efficacy of various complementary and alternative medicine (CAM) therapies to reduce cancer pain

The type of article is systematic review.

• Databases searched were MEDLINE, EMBASE, CINAHL, Allied and Complementary Medicine (AMED), and the Cochrane Library up to August 2005. Investigators also searched reference lists from articles to identify relevant studies.
• Search keywords were cancer, pain and alternative medicine, and neoplasm, as well as terms for major individual CAM therapies.
• Studies were included in the review if they were randomized clinical trials (RCTs) that had a CAM intervention for cancer pain.
• Exclusion criteria were not cited.

The initial search identified 101 articles, of which investigators excluded 85. Investigators included an additional two articles, which were found through manual scans of reference lists. Investigators appraised articles by using the Jadad scale.

• The final sample included 18 studies reporting on 1,499 patients.
• The average sample included less than 100 patients; median sample size was 54 patients.

• Acupuncture: Investigators evaluated three trials, of which one was a high-quality study that used auricular acupuncture to treat 90 patients. Compared to the placebo group, the treatment group had a significant decrease in pain intensity that lasted two months.
• Mind-body interventions: Investigators assessed five trials. Two of these were trials of intermediate quality in which support groups were effective in decreasing pain. Interventions included group supportive psychotherapy, hypnosis, and support groups. Two trials concluded that relaxation and imagery were effective in reducing pain. Researchers obtained no greater relief by adding cognitive behavioral therapy to relaxation or imagery.
• Music: Assessment revealed that the three trials were of poor quality. Results were mixed. Effects measured were of very short duration.
• Herbal mixtures: Two trials examined different herbal supplements. Both trials were of poor quality, and one did not report actual statistical results. Authors could draw no meaningful conclusions from this information.
• Massage therapy: The four trials involving massage therapy had mixed results in terms of efficacy. Most of these trials had very small sample sizes, and none found intervention effects that lasted longer than four weeks.
• Healing touch or Reiki: Two trials involved these interventions. Results did not warrant conclusions about effectiveness.

The result of this systematic review was that none of these interventions can be recommended as effective. The most promising therapies appear to be mind-body interventions. In particular, hypnosis and relaxation might have some effect in decreasing cancer pain. Effect may be limited by cognitive impairment caused by cancer or cancer treatment. Support groups may have some positive effects. Whether these benefits are due to increased patient awareness, with more frequent visits to care providers, better compliance with medication regimens, or as a result of group interaction and social or emotional support is unclear. One study found that benefit occurred only in those patients who were more distressed at baseline. It is possible that effect sizes of therapies may be more discernible among patients with higher pain ratings, demonstrating a floor effect related to the symptom of pain.

• Most trials were of low quality, with missing data and incomplete reporting. This fact made extracting sufficient usable information difficult.
• Few studies in the analysis examined a specific intervention.

Current evidence does not support the efficacy of the cited CAM interventions in the management of pain of patients with cancer. Methodologically strong research that incorporates appropriate attentional and sham controls, sufficient sample sizes, and longer duration of follow-up is needed.

To determine the efficacy of a mouthwash solution composed of verbascoside, polyvinylpyrrolidone, and sodium haluronate (Mucosyte) in the treatment of chemotherapy-induced oral mucositis (OM)

Patients undergoing chemotherapy for acute lymphoblastic leukemia (ALL) on the same protocol treatment (ALL 2009 standard protocol) were included in the study. Patients were randomized to either the group A (intervention group) or group B (placebo group). Each group were to rinse with 15 ml of the solution for two minutes three times a day for a total of eight days. OM scoring was conducted on day 1 (day of diagnosis of OM), three days after treatment, and again on day 8. Pain scores were determined at the same time as the oral examination for the OM scoring.

• N = 56   
• AGE = 5–18 years
• MALES: 9 (intervention), 13 (placebo), total = 39%  
• FEMALES: 19 (intervention), 15 (placebo), total = 61%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: ALL
• OTHER KEY SAMPLE CHARACTERISTICS: Grade 1 or 2 OM

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Italy

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Randomized, double-blinded study. Each participant was randomized with an automatically generated list.

• Common Toxicity Criteria for Adverse Events (CTCAE) and scale of the WHO to grade OM
• Visual analog scale (VAS) used to score pain level

Group A showed a reduction in OM of T1 on day 3. On day 8, group A and group B had a reduction of T2, with group A revealing a statistically significant decline compared to group B (p = 0.0038). Group A showed a reduction in pain scores for both TI and T2, resulting in a reduction in additional analgesia needed, compared to group B.

The use of Mucosyte mouthwash in children with chemotherapy-induced OM revealed a reduction in the grade of OM and pain scores during an eight-day treatment and, therefore, may be recommended as a supportive treatment.

Small sample (< 100)

The implications of this study are promising for treatment with Mucosyte mouthwash for reducing OM and pain during chemotherapy for ALL. More studies may need to be conducted, because this study took into account only patients on the same treatment regimen. Other treatment regimens including chemotherapy, radiation, and or laser therapy may affect the severity and duration of OM and, therefore, may reveal different results.

To assess the effectiveness of self-massage and skin care using a base cream containing aromatherapy oils versus using a base cream without aromatherapy oils in terms of objective reduction in limb volume and patient-reported symptom improvement and well-being after simple lymphatic drainage

• The sample (N = 81) was comprised of patients who were randomized to either the experimental group (n = 40) or the control group (n = 41).
• The majority of patients were female (n = 77), with only four male patients.
• Age of the sample ranged from 25–80 years.
• Patients were included in the study if they
  • Were referred to the Dorset Cancer Centre Lymphedema Service
  • Had lymphedema for more than one year
  • Had bilateral or unilateral stable lymphedema
  • Had no evidence of acute inflammation, thrombosis, or recurrence
  • Agreed to avoid other aromatherapy-based treatments and products during their treatment period
  • Were not pregnant or sensitive to aromatherapy or wheat germ.

• Circumference was measured every 4 cm using a self-tensioning tape measure and recorded as absolute volume.
• Truncated cone calculation was used to calculate volume.
• Measurements were taken monthly for three months.
• If no improvement was seen over three months, patients were taken off the trial and returned to standard hospital therapy.
• Symptom improvement, activity, and well-being were measured using the Measure Yourself Medical Outcome Profile 2 (MYMOP2).

Self-massage and skin care significantly improved patient-identified symptom relief and well-being for patients. It also, but not significantly, reduced limb volume. Aromatherapy oils did not appear to influence any improvement in these measures. In the experimental group, 69% had limb reduction, compared to 57% in the control group (p = 0.38). Both groups combined showed slight improvement (p = 0.034). The finding supports the use of simple lymphatic drainage. Well-being, pain, discomfort, mobility, and body image were evaluated and showed significant improvement in patient-identified symptom relief and well-being. No difference was observed using aromatherapy.

• Determining the value of subjective benefits was difficult, even using the scale.
• The study used both primary and secondary patients.
• The study sample was not a very homogeneous group, presenting too many variables.
• Patients did not necessarily have a cancer diagnosis.
• The cause of lymphedema was not defined.

RCT was designed to evaluate pain control and the ability to eat and drink using standard therapy (sucralfate and Mucaine® [Wyeth-Ayerst Laboratories]) versus Gelclair®  (EKR Therapeutics, Inc.) in patients with radiotherapy-induced oral mucositis.

Patients used medication 30 minutes to 1 hour before eating or drinking.

Gelclair: Patients used undiluted or could mix a single dose in a glass with up to 40 ml of water. Patients swished and gargled for at least one minute to coat the tongue, roof of mouth, throat, and inside of cheeks. If unable to do that, patients used sponge applicators. Patients spat the product out and did not swallow it.

Sucralfate and Mucaine: Patients swished 10 ml in mouth for at least 1 minute to coat all areas, then swallowed the product.  

Study was 24 hours only. Baseline was 1, 3, and 24 hours after initiation of treatment.

Patients in both groups had additional analgesia available throughout the trial.

Patients swallowed standard therapy but not Gelclair.

 

The sample was comprised of 20 patients (n = 10 in the Gelclair group and n = 10 in the standard [sucralfate and Mucaine] group).

Patients with head and neck cancer received daily radation therapy over a 4–6 week period and showed at least grade 1 oral mucositis and pain not alleviated by paracetamol, co-codamol, or aspirin.

The mean age was 61.1 years (range = 28-79 years).

Three patients were smokers.

 

Double-center, prospective RCT

Single blind trial with the administrating nurse specialist unaware of medication used

Conducted as feasibility study for future sample size calculation

Oral mucositis NCI-CTC for radiation

General pain and pain on speaking VAS 0–10

Swallowing assessment was self-recorded (normal to swallowing own saliva only).

Compliance was queried by the researcher.
 

Using NCI grading, nine patients had grade 3 or 4 (three in the intervention arm and six in the control arm). The remaining 11 patients had grade 1 or 2 (seven in the Gelclair group and four in the standard therapy group).

No observations of relevance with regard to general pain, pain on speaking, or ability to eat and drink for those with higher grades of oral mucositis.

Number of coanalgesics of strong opiate type

One patient was noncompliant for sucralfate and Mucaine.

General pain: No significant difference was observed between the intervention and the control group across time intervals (p = 0.236).

Reduction in pain on speaking was not significant (p = 0.616).

Swallow: Effects of standard therapy appeared to last longer than Gelclair (NS).
 

Because the study was only 24 hours, effectiveness with more severe mucositis is not known.

 

To explore the relationships between adult cancer survivors’ and caregivers’ social support, self-efficacy for physical activity, physical activity, and quality of life, and to understand their perceptions of social support in physical activity participation

Participants attended the FitSTEPS for Life^® (FSFL) for one month. FSFL is an individually tailored and supervised community-based exercise program for cancer survivors and their caregivers established by the Cancer-Foundation For Life nonprofit organization. Survivors required a referral from their oncologists to be able to attend FSFL and were expected to exercise at least three times a week.

Only data on caregivers were included in this summary.

• N = 39 at baseline (eight at follow-up)  
• MEAN AGE = 62.1 years (SD = 13.8 years)
• MALES: 10 (25.6%), FEMALES: 29 (74.4%)
• KEY DISEASE CHARACTERISTICS: Caregivers of patients with various cancers and stages
• OTHER KEY SAMPLE CHARACTERISTICS: Adults; 30 of 39 were Caucasian; 21 of 24 used mobility devices; able to read, write, and comprehend English; paid caregivers were excluded

• SITE: Multi-site    
• SETTING TYPE: Other  
• LOCATION: East Texas and Dallas

• PHASE OF CARE: Late effects and survivorship

Mixed-method, quasi-experimental study with written responses to questions and recorded interviews of the caregivers of patients who enrolled in FSFL based on oncologist referrals

• Quantitative
  • Social Support and Exercise Survey
  • The Exercise Confidence Survey for self-efficacy for physical activity (SEPA)
  • The 8 Foot Up and Go functional fitness test for physical activity (PA) participation
  • Quality of Life Short Form 8 (SF-8)
• Qualitative
  • Written responses to open ended-question “please tell us how social support affects your PA each day” at baseline and one month later; and interviews face to face and on the phone responding to a semistructured interview that were recorded and transcribed verbatim.

Participation in FSLP did not have a significant effect on caregivers' PA, quality of life, social support, or SEPA. Qualitative data supported relationships between social support, PA, and quality of life.

• Small sample (< 30): Only eight caregivers completed the one-month follow-up questionnaire
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Questionable protocol fidelity

Nurses should consider the role of social support in designing interventions to influence the PA, self efficacy, and quality of life of caregivers. Nurses should encourage cancer survivors and their caregivers to openly discuss their needs for social support. This study was too small to evaluate the effects of exercise, and the high drop out rate suggests that continued involvement in this type of effort may not be acceptable for patients and caregivers.

The intervention consisted of once weekly art therapy sessions to teach patients to act in a more conscious way by painting with water-based paints. The intervention was provided by an art therapist. The duration of the sessions varied. Those who completed four or more sessions (n = 19) were compared to those who participated for two weeks or less (n = 41).

• The sample was comprised of 60 adult ambulatory patients (77% female, 23% male) who were undergoing chemotherapy.
• Mean age was 77 years (range 25–72).
• Patients were excluded from the study if they had severe anemia; were treated with an epoetin; had changed their opiate, non-selective serotonin reuptake inhibitor (SSRI) antidepressant, or anxiolytic in the past three weeks; or had changed their SSRI antidepressant in the past six weeks.

The study was conducted in an ambulatory setting of a cancer center in northern Israel.

The study used a single-arm, open-label design.

• Brief Fatigue Inventory (BFI), competed weekly before each session
• Hospital Anxiety and Depression scale (HADS), competed weekly before each session

• Median BFI score decreased from 5.7 to 4.1 in the intervention group (p = 0.24).
• Median HADS decreased from 9 to 7 in the intervention group (p = 0.21); anxiety was normal.

• The control group had greater fatigue and may not have been able to participate.
• The study lacked randomization.
• The study did not provide control data related to patient drop-out or chemotherapy.
• Cycle or day-in-cycle assumptions regarding mediating the effect of decreased emotional distress were untested.

For treatment with art therapy, a patient requires referral to an art therapist.

An anthroposophy art therapy intervention (watercolor painting) in weekly group sessions was administered by an art therapist in northern Israel. Participants chose the amount of time to spend in the session, ranging from a few minutes to more than an hour. Data were collected at baseline and before every session.

• The study reported on a sample of 60 oncology inpatients and outpatients who were receiving chemotherapy, radiotherapy, or follow-up care.
• Patients in the intervention group (n = 19) completed four or more art sessions.
• Patients in the participation group (n = 41) completed one to three art sessions.

A single-arm, pilot study design was used.

• Hospital Anxiety and Depression Scale (HADS)
• Brief Fatigue Inventory (BFI)

A Mann-Whitney U test compared HADS and BFI in the intervention group and the participation group. A Wilcoxon signed-rank test assessed changes in HADS and BFI scores in the two groups. There were no significant difference between the two groups for reducing anxiety (p = 0.2).

• Anxiety levels at baseline were in the normal range for both groups.
• The small sample size of unspecified types of cancer and varying treatments, lack of statistically significant findings, and lack of randomization or control group limited this study.
• A specialized art therapist was needed to administer the intervention.

To observe the clinical effectiveness of a topical application of Xiaozheng Zhitong Paste (XZP) in alleviating the cancerous pain of patients with middle/late-stage cancer

Patients were randomized into either the treatment group (64 patients) or the control group (60 patients). In addition to utilization of three-ladder (3L) analgesia therapy in both groups, topical application of XZP was given to patients in the treatment group for pain alleviation. Analgesic efficacy was recorded in terms of pain intensity, analgesia initiating time and sustaining time, and the optimal analgesic effect revealing time. Quality of life and adverse reactions that occurred in patients were also recorded.

• The study reported on 124 patients.
• Mean patient age in the treatment group was 69 years (range = 58–74 years); mean patient age in the control group was 67 years (range = 56–75 years).
• The treatment group was 56% female and 44% male; the control group was 65% female and 35% male.
• Patients estimated their pain degree by the verbal rating scale (VRS) as greater than 4; had received 3L analgesia without adequate control, and required an increase or change in dosing. The pain was localized, with the number of pain sites being less than four, and suitable for external compression with no skin damage, edema, or heat.
• Patients were older than age 18, had no allergy history, had no psychiatric illness, had normal language expression, and were able to self-report.

• Inpatient oncology
• Department of oncology, Guang’anmen Hospital

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for end-of-life and palliative care.

The extent of pain, the analgesic effect initiating time and sustaining time of medication, and the optimal effect revealing time were recorded before medication and 24 hours after medication. Quality of life was estimated by Karnofsky scoring and the Brief Pain Inventory (BPI).

Intensity of pain was evaluated per standards of the World Health Organization with the numeric rating scale (NRS), expressed as digits from 0–10 (0 for no pain, 10 for extreme pain). Intensity of pain was ranked into four grades: 0 = no pain; grade I = endurable pain, normal daily life, sleep not affected, NRS 1–3; grade II = obvious pain, unendurable, patients asked for analgesia, daily life and sleep affected, NRS 4–6; grade III = severe pain, could hardly endure, analgesia necessary, sleep interfered with, impact on motion, forced posture, painful complexion, and incessant groaning, NRS 7– 10.

Effectiveness on pain treatment was classified into four grades: completely remitted (CR), partially remitted (PR), mildly remitted (MR), and no palliation (NP). Comparison of the total effective rate (sum of CR+PR+MR) between the two groups showed no significant difference (p > 0.05). Analgesic effect initiating time was decreased, and its sustaining time was elongated in both groups after medication (p < 0.01), but the initiating time was shorter in the treatment group than in the control group (p < 0.01). The mean optimal analgesia effect was shorter in the treatment group, demonstrating a significant difference (p < 0.01).

Compared by the effect of pain on patients, the effect was attenuated by both groups after medication, but the mental condition, walking capacity, social acceptability, sleep, and joy of living were all better with those in the control group, showing statistical significance (p < 0.01).

The combination of 3L analgesia and XZP compress demonstrates the similar effects in pain alleviation as compared with 3L analgesia alone.

XZP paste was prepared at the pharmaceutical department of the author’s hospital.

Chinese medicine may prove to be beneficial for patients with cancer-associated pain management issues, as well as in end-of-life and palliative care; however, these findings do not provide support for the intervention tested here. Nursing participation in these evaluations is essential.