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Matsuura, M., Satohisa, S., Teramoto, M., Tanaka, R., Iwasaki, M., Nishikawa, A., . . . Saito, T. (2015). Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following paclitaxel and carboplatin in patients with gynecologic cancers: A randomized, multicenter, phase-II trial. The Journal of Obstetrics and Gynaecology Research, 41, 1607–1613. 

Study Purpose

To examine the proportion of patients who achieve a complete response (no emetic episodes and no rescue medication during the overall phase in each arm) with the treatment

Intervention Characteristics/Basic Study Process

Patients were receiving chemotherapy with carboplatin and paclitaxel for a gynecologic malignancy. All patients received a single IV dose of palonosetron (0.75 mg) on day 1 as a bolus given 30 minutes prior to chemotherapy, dexamethasone at 9.9 mg if patients were on dose-dense chemotherapy, and 20 mg for traditional carboplatin paclitaxel within 45 minutes prior to chemotherapy. Patients were then randomly assigned to two groups. Dexamethasone 8 mg was given on days 2 and 3, but no additional dexamethasone. Rescue medication was allowed. Evaluation of emetic events and nausea were measured using a diary and a 4-stage Likert-type scale. Randomization was done at a registration center with a minimization method with stratification according to institution, cancer type, age, and chemotherapy regimen.

Sample Characteristics

  • N = 109   
  • AGE = 45–68 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Ovarian, endometrial, or cervical cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Type of regimen, either conventional paclitaxel 175 mg/m2/carboplatin AUC 6 every three weeks or dose dense with carboplatin AUC 6 on day 1, taxol 80 mg/m2 on days 1, 8, and 15; alcohol consumption, motion sickness, and age; patients were chemotherapy naïve or had received single-agent low emetogenic potential therapy

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled, non-placebo trial

Measurement Instruments/Methods

  • Used a patient diary to evaluate emetic events and nausea
  • Nausea was measured using a 4-stage Likert-type scale.
  • Multivariate logistic regression analysis showed relationships to other variables, such as motion sickness.
  • Complete control was measured as no emetic episodes, no rescue medications, and mild nausea.
  • Total control was defined as no emetic episodes, no rescue medications, and no nausea.

Results

In the overall period, total control was 49.1% in the three-day dexamethasone group and 37.5% of the one-day dexamethasone group. In the acute phase, it was 90.6% in the three-day group and 92.9% in the one-day group. For delayed, it was 50.9% in the three-day group and 39.3% in the one-day group. Complete control in the overall period was 67.9% in the three-day group and 58.9% in the one-day group. In the acute phase, it was 98.1% in the three-day group and 96.4% of the one-day group. When looking at the responses, there were differences with motion sickness (p = 0.037), favoring the three-day dexamethasone regimen.

Conclusions

The authors concluded that one day of dexamethasone is as effective as three days of dexamethasone, except in special populations, such as those with motion sickness or severe hyperemesis gravidarum. Differences in efficacy were not found in patients with other risk factors, such as alcohol use and age.

Limitations

Findings not generalizable

Nursing Implications

Nurses play a key role in assessing patient risk for chemotherapy-induced nausea and vomiting. Knowing past history of morning sickness or motion sickness should clue nurses into collaborating with providers to consider three days of dexamethasone as opposed to one day.

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Matsuoka, H., Makimura, C., Koyama, A., Otsuka, M., Okamoto, W., Fujisaka, Y., . . . Nakagawa, K. (2012). Pilot study of duloxetine for cancer patients with neuropathic pain non-responsive to pregabalin. Anticancer Research, 32,1805–1809.

Study Purpose

To investigate the effect of duloxetine for cancer-related neuropathic pain in patients for whom treatment with pregabalin was unsuccessful

Intervention Characteristics/Basic Study Process

Data were retrospectively reviewed for patients experiencing neuropathic pain who were treated with duloxetine because pregabalin could not be administered, was ineffective, or where the dosage could not be increased due to side effects. Patients were given 20 mg of duloxetine per day, increased to 40 mg/day if needed. Pain was assessed for two weeks.

Sample Characteristics

  • The study reported on a sample of 15 patients. 
  • Patient age range was 31–79 years.
  • The sample was 60% male and 40% female.
  • Cancer diagnoses included breast, colon, and lung.
  • Most patients were also receiving strong opioids.

Setting

  • Single site
  • Outpatient setting
  • Japan

Study Design

A retrospective study design was used.

Measurement Instruments/Methods

Numeric rating scale for pain

Results

Pain was reduced in 7 of the 15 patients. Baseline pain ranged from 5 to 10. After two to four weeks, pain ratings ranged from 2 to 9.

Conclusions

Duloxetine may be effective for relief of neuropathic pain.

Limitations

  • The study has a small sample, with less than 30 participants.
  • The study has risk of bias due to no control group, no blinding, and no random assignment.
  • There was no magnitude analysis of individual pain rating changes.
  • There was no discussion of opioid dose changes, or any use of breakthrough medications.
  • It appears that pain rating was done at a single time point per week; it is not clear whether this was self-report or of average, current, or worst pain.

Nursing Implications

Findings suggest that duloxetine may be helpful for patients with neuropathic pain as an alternative to pregabalin. This study provides weak evidence due to multiple study limitations. Further well-designed research is needed to identify the most effective management for cancer-related neuropathic pain.

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Matsuda, C., Munemoto, Y., Mishima, H., Nagata, N., Oshiro, M., Kataoka, M., . . . Kono, T. (2015). Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis. Cancer Chemotherapy and Pharmacology, 76, 97–103.

Study Purpose

To determine if TJ-1 (hangeshanshinto), a Japanese traditional herbal medicine, prevents and controls chemotherapy-induced oral mucositis

Intervention Characteristics/Basic Study Process

Patients who developed greater than World Health Organization (WHO) grade 1 oral mucositis during the first screening cycle of chemotherapy were eligible for a central 1:1 randomization to the study or control group. Three times each day, patients dissolved 2.5 g of TJ-14 or a placebo in 50 ml of water and rinsed the oral cavity. Patients were trained in the clinic. Treatment started on the first day of chemotherapy and continued for 14 days. Assessments using the WHO oral mucositis scale were done three times per week on nonconsecutive days during the screening cycle and treatment cycles 1 and 2. Assessments continued for three weeks or until mucositis returned to grade 0. Safety and adverse events were assessed.

Sample Characteristics

  • N = 90  
  • MEDIAN AGE = 67 years (range = 49–84 years) 
  • MALES: 55.5%, FEMALES: 44.5%
  • KEY DISEASE CHARACTERISTICS: Chemotherapy-induced oral mucositis in patients with colorectal cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: Fluorinated pyrimidine-based chemotherapy

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Multi-institutional, double-blinded, placebo-controlled, randomized, phase 2 trial

Measurement Instruments/Methods

  • World Health Organization (WHO) mucositis grading

Results

There was no significant difference in the incidence and severity of oral mucositis between the groups. The duration of grade ≥ 2 mucositis was 5.5 days in the treatment group and 10.5 days in the placebo group.

Conclusions

This study did not meet its primary endpoint. TJ-14 demonstrated a potential treatment effect on mucositis ≥ grade 2 .

Limitations

  • Small sample (< 100)

Nursing Implications

TJ-14 is a Japanese traditional herbal medicine consisting of a mixture of seven herbs. Additional study is needed to fully evaluate its effectiveness.

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Matourypour, P., Vanaki, Z., Zare, Z., Mehrzad, V., Dehghan, M., & Ranjbaran, M. (2016). Investigating the effect of therapeutic touch on the intensity of acute chemotherapy-induced vomiting in breast cancer women under chemotherapy. Iranian Journal of Nursing and Midwifery Research, 21, 255–260.

Study Purpose

To determine the effect of therapeutic touch on chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to one of three groups, control receiving no intervention, therapeutic touch, and a placebo intervention. The researcher received training in therapeutic touch and performed these interventions. In the placebo group, the researcher moved her hand around the body to pretend an act of therapeutic touch. CINV was assessed immediately before the intervention and again 24 hours after chemotherapy. Patients were receiving triplet antiemetic prophylaxis.

Sample Characteristics

  • N = 108   
  • MEAN AGE = 49.7 years (SD = 9.2 years)
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving cyclophosphamide and epirubicin
  • OTHER KEY SAMPLE CHARACTERISTICS: Most had less than a high school education and had no income.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Single-blind, placebo-controlled, randomized trial

Measurement Instruments/Methods

  • Vomiting intensity was measured on a 0–3 point scale (prior validity measurement was 0.86).

Results

Vomiting intensity was lower in the intervention group compared to the controls (p < 0.0001), but no difference existed between the intervention and placebo groups.

Conclusions

The study results suggested that therapeutic touch may provide a placebo effect to reduce CINV. The efficacy of actual therapeutic touch was not demonstrated compared to placebo.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement validity/reliability questionable
  • The CINV measurement method was not a commonly used approach, and no information was provided on various response rates.
  • No information about use of rescue antiemetics was provided, although the methods state that the patients were ordered metoclopramide. 
  • The analysis was unclear, as data was reported in terms of ranking rather than actual outcome measures as collected.

Nursing Implications

The findings did not show the effectiveness of therapeutic touch compared to a placebo intervention to prevent CINV. They do suggest a potential placebo effect for therapeutic touch. This study had several limitations.

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Mattila, E., Leino, K., Paavilainen, E., & AstedtKurki, P. (2009). Nursing intervention studies on patients and family members: A systematic literature review. Scandinavian Journal of Caring Sciences, 23, 611–622.

Purpose

To identify the targets of intervention studies and obtain findings that will help in planning future intervention studies, support nursing, and promote the introduction of new family-centered nursing methods

Search Strategy

  • MEDLINE and CINAHL (2001–2006) databases were searched, in addition to hand searching of article references.
  • Key words were nursing interventions, family, family health, family nursing, family members, caregivers, and spouse.
  • Inclusion criteria included English-language studies with participants who were at least 18 years of age.
  • Patients and family members, or family members only, described or tested a nursing intervention and its impact.

Literature Evaluated

The initial search yielded 323 articles. The final analysis included 31 articles that met inclusion criteria. Evidence was assessed using the Finnish Federation of Nurses’ criteria, which is described in the article. Content analysis of interventions was used. The RE-AIM model was used to examine study findings. This model includes dimensions of reach, efficacy, adaptation, implementation, and maintenance. Only six of the studies were identified as a high level of evidence using the stated criteria.

Sample Characteristics

  • A final sample of 31 studies was used.
  • Study sample sizes were not reported.
  • Sample characteristics were not fully described, but the authors stated that the majority of interventions were aimed at patients with cancer.
  • Other situations included patients with Alzheimer disease, dementia, stroke, and schizophrenia and their family members.

Results

  • Of the studies, 22 used quantitative methods, 4 used qualitative methods, and 5 used a combination of these.
  • Support and counseling interventions on depressive symptoms of spouses of patients with Alzheimer disease were supported by the evidence.
  • Education and support interventions were shown to help improve family members’ ability to control challenging behavior associated with Alzheimer disease and schizophrenia.
  • Support and teaching interventions may enhance preparedness and social capability and alleviate depressive symptoms in family members of patients who experienced a stroke.
  • Support and teaching interventions may help to improve quality of life in family members of patients with cancer.
  • Interventions ranged in duration from 4 to 24 weeks and involved a variety of personal and group meetings and/or phone contact.
  • The majority of studies were focused on a single family member and did not consider the wider family context.

Limitations

  • The studies included difficult categories of patients and families (e.g., cancer dementia) that have very different problems and needs, thereby decreasing the applicability of the results.
  • Data from the studies was incomplete, such as dropout rates and missing data (particularly the differential dropout rate).
  • Not all of the dimensions of RE-AIM were able to be assessed due to insufficient data.

Nursing Implications

  • Interventions were not designed to achieve economic objectives, and consideration was not given to the costs of the intervention.
  • Overall, interventions may be effective in alleviating burdens of care and depressive symptoms of family members, as well as assisting their coping. 
  • These nursing interventions are in development and testing stages. Long-term effects and aspects of maintenance and implementation monitoring are not clear.
  • Nursing interventions involving education, counseling, and incorporation of both individual and group activities can be effective in assisting caregivers. The most effective combinations of approaches, setting for provision, and long-term maintenance are not yet clear.
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Massa, E., Astara, G., Madeddu, C., Dessi, M., Loi, C., Lepori, S., & Mantovani, G. (2009). Palonosetron plus dexamethasone effectively prevents acute and delayed chemotherapy-induced nausea and vomiting following highly or moderately emetogenic chemotherapy in pre-treated patients who have failed to respond to a previous antiemetic treatment: Comparison between elderly and non-elderly patient response. Critical Reviews in Oncology/Hematology, 70, 83–91. 

Study Purpose

To determine the effectiveness of palonosetron in prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) for highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) in patients who had failed to respond to a different antiemetic 5-HT3 antagonist during the first cycle; to determine differences in response between older adults and younger patients

Intervention Characteristics/Basic Study Process

On day 1, patients received 16 mg dexamethasone plus 250 mcg IV palonosetron before chemotherapy administration. For prophylaxis, patients received 8 mg dexamethasone every 12 hours on days 2–3 and 4 mg dexamethasone every 12 hours on days 4–5. Metoclopramide (20 mg) intramuscular was used at a maximum dose of 80 mg as rescue medication to treat CINV. Patients were asked to record daily episodes of vomiting, nausea, and use of rescue medication daily through day 5.

Sample Characteristics

  • The study sample consisted of 47 participants.
  • Mean age was 60.7 years (SD = 3 years). Older adults (age 65 or older) had a mean age of 72.3 years (SD = 6 years), and those under age 65 had a mean age of 60.7 years (SD = 3 years).
  • The majority of patients (59.6%) were male.
  • Diagnoses included tumors at various sites (head and neck, lung-pleural mesothelioma, colorectal, ovary, breast, pancreas, prostate, malignant lymphoma, melanoma, sarcoma, biliary ducts, bladder, and stomach), stages II–IV.
  • The chemotherapy regimen was the same as that of previous chemotherapy administered for the first cycle and for which the previous antiemetic treatment failed. Regimens were moderately or highly emetogenic.

Setting

The setting was not reported.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a prospective design, phase II, open, nonrandomized trial.

Measurement Instruments/Methods

The following were measured.

  • Daily episodes of vomiting (number, duration, and time from chemotherapy administration), vomiting according to Common Terminology Criteria for Adverse Events (CTCAE 3.0) for days 1–5
  • Nausea (grade 3–4, according to CTCAE 3.0) on days 1–5
  • Use of rescue medication on days 1–5
  • Complete response (CR), defined as no emetic episodes and no use of rescue medication during the first 24 hours (acute), and during 24–120 hours (delayed) following chemotherapy
  • Complete control (CC), defined as no emetic episodes, no need for rescue medication, and no more than mild nausea in the acute, delayed, and overall periods

Results

  • CR and CC for the acute, delayed, and overall phases were not statistically different with the intervention between older adult and younger subjects, compared to the subsequent cycles of chemotherapy after intervention.
  • Grade 1–2 toxicities were observed without group differences.
  • The most frequently reported adverse events were constipation and anxiety.

Conclusions

Single-dose palonosetron (250 mcg) should be considered a safe second generation 5-HT3 antagonist in the prevention of nausea and vomiting induced by HEC or MEC, irrespective of patient age.

Limitations

  • The study had fewer than 100 participants.
  • The study combined HEC and MEC together but did not include aprepitant.
  • The authors in this study concluded that palonsetron is older-adult friendly because the comparison between older adult and younger participants found no difference. However, younger age is a well-known predisposing factor for CINV.
  • The sample consisted of patients who previously failed 5-HT3.
  • Anticipatory nausea would be likely but was not discussed.

Nursing Implications

Palonosetron provides control of CINV regardless of patient age.

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Massa, E., Madeddu, C., Lusso, M.R., Gramignano, G., & Mantovani, G. (2006). Evaluation of the effectiveness of treatment with erythropoetin on anemia, cognitive functioning and functions studied by comprehensive geriatric assessment in elderly cancer patients with anemia related to cancer chemotherapy. Critical Reviews in Oncology/Hematology, 57(2), 175–182.

Study Purpose

The study's primary aim was to examine the relationship of changes in Hgb levels following erythropoietin treatment to changes in cognitive functioning, as studied in older adult patients with cancer undergoing chemotherapy treatment. Its secondary aim was to assess the relationship of changes in Hgb levels following erythropoietin treatment to changes in functions studied in the Comprehensive Geriatric Assessment.

Intervention Characteristics/Basic Study Process

The study's treatment cycle was 12 weeks. For the first 2 weeks, all patients were treated with 10,000 units of erythropoietin twice daily for 6 days a week. For the following 10 weeks, participants were administered 10,000 units of erythropoietin 3 times a week. Participants were also treated with 125 mg of intravenous sodium ferric gluconate complex weekly, or more than once a week if serum iron values were below the inferior limit of normal range. All assessments, including cognition (as based on the MMSE) were completed at baseline prior to treatment with erythropoietin, and at weeks 4, 8, and 12 of treatment.

Sample Characteristics

  • The number of participants was 10.
  • The average participant age was 71.4, with a range of 68–75.
  • 50% of participants were female and 50% were male.
  • 40% of participants had non–small-cell lung cancer, 10% had oral cancer, 10% had ovarian cancer, 10% had breast cancer, 10% had endometrial cancer, 10% had colon cancer, and 10% had stomach cancer.
  • All participants had an ECOG performance status of 0–2 and an initial MMSE score of 19 or greater. 

Setting

The study took place at a single-site location in Italy. 

Study Design

The study was a prospective single-arm trial.

Measurement Instruments/Methods

The Mini-Mental State Examination (MMSE) measured global cognitive function.

The Comprehensive Geriatric Assessment (CGA) is a multidimensional, interdisciplinary diagnostic process that determines the medical, psychological, and functional capabilities of a frail elderly person. It includes

  • Activities of Daily Living Scale (ADL). Scores ranging between 0–8 were used to assess functional status for self-care activities.
  • Instrumental Activities of Daily Living Scale (IADL). Scores ranging between 0–8 were used to assess functional status for higher-level activities.
  • Geriatric Depression Scale (GDS), a 15-item questionnaire.
  • The Mini Nutritional Assessment (MNA).

Results

Nine participants (90%) showed significant improvement in cognitive function compared to baseline (p < 0.005), with eight of these patients also responders to erythropoietin in showing correction of anemia. All of these patients maintained improved MMSE scores after weeks 8 and 12 (p = 0.009 and 0.006). There was significant correlation between changes in Hgb levels and cognitive functioning (p = 0.049). There were no significant changes in ADL, IADL, GDS, or MNA scores as compared to baseline scores.

At baseline, the mean Hgb level was 10.3 g/dL, and 40% of patients displayed cognitive impairment (MMSE score < 24). After four weeks of treatment, Hgb levels increased significantly (p < 0.001). 

Conclusions

The study found that treating anemic patients undergoing chemotherapy significantly improved anemia, and that this improvement was correlated with an improvement in cognitive function. However, definitive conclusions cannot be drawn from this study because of multiple limitations.

Limitations

  • The study had a very small sample size for the participants' multiple types of cancer, regimens, and variability in stage of disease.
  • The study lacked a control group as a comparison.
  • All patients were anemic at baseline.
  • The MMSE is not sensitive enough to detect subtle cognitive changes.
  • There was a lack of alternate forms for repeated administration of MMSE, so practice effects may have influenced study outcomes.
  • The study followed an atypical erythropoietin dosing schedule.
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Maschmeyer, G., Beinert, T., Buchheidt, D., Cornely, O. A., Einsele, H., Heinz, W., . . . Mattiuzzi, G., (2009). Diagnosis and antimicrobial therapy of lung infiltrates in febrile neutropenic patients:  guidelines of the Infectious Diseases Working Party of the German Society of Haematology and Oncology. European Journal of Cancer, 45, 2462–2472.

Purpose & Patient Population

Patients with febrile neutropenia who developed lung infiltrates were included.

Type of Resource/Evidence-Based Process

In these guidelines, prospective clinical trials involving patients with febrile neutropenia and lung infiltrates were reviewed. 

Categories of Evidence Used: 

Strength of Evidence:

  • (A) Good evidence to support a recommendation for use
  • (B) Moderate evidence to support a recommendation for use  
  • (C) Poor evidence to support a recommendation
  • (D) Moderate evidence to support a recommendation against use
  • (E) Good evidence to support a recommendation against use. 

Quality of Evidence:

  • (I) Evidence from ≥1 well-designed clinical trials
  • (II) Evidence from  ≥1 well-designed clinical trials, without randomization; from cohort or case-controlled analytic studies (preferably from >1 center); from multiple time series; or from dramatic results from uncontrolled experiments 
  • (III) Evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Search Strategy

Databases searched were not specified.

Search keywords were lung infiltrate, treatment, aspergillosis, febrile neutropenia, and infection.

Patients receiving allogeneic hematopoietic stem cell transplantations were excluded.

Results Provided in the Reference

Using systemic antifungals that are mold-active can improve outcomes for patients with neutropenia that has been present 10 or more days and who have developed fever and lung infiltrates (BII).  The recommended pre-emptive (i.e., administration of antimicrobial agents on the basis of clinical, imaging, or laboratory findings indicative of a particular infection in patients at risk for, but without proof of, this infection) antifungal therapy is voriconazole or liposomal amphotericin B.  Much of the content in this guideline is related to diagnosing and managing infections for neutropenic patients with lung infiltrates, not preventing infection, but reducing the risk of second and subsequent infections.

Guidelines & Recommendations

Specific pre-emptive therapy with voriconazole or liposomal amphotericin B in neutropenic patients can improve outcomes (BII).  Patients with cancer who are neutropenic and have respiratory failure–related lung infiltrates have better outcomes if transferred to intensive care units for care, including mechanical ventilation (AII).

Limitations

Conflicts of Interest: Georg Maschmeyer has been a consultant for Gilead Sciences, MSD, Pfizer, Essex (Schering-Plough), Novartis, and Sanofi-Aventis and has been on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Cephalon.  Dieter Buchheidt receives grants and research support from Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough) and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough).  Oliver Cornely has received grants and research support from Astellas, Basilea, Gilead Schinces, MSD, Pfizer, Essex (Schering-Plough), and Cephalon and has been a consultant for Astellas, Basilea, F2G, Gilead Sciences, MSD, Pfizer, Essex (Schering-Plough), and Cephalon and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Cephalon.  Hermann Einsele has been a consultant for MSD.  Werner Heinz has received grants and research support from Astellas, Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough); has been a consultant for Pfizer and Essex (Schering-Plough); and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough).  Claus Peter Heussel has received research support and grants from AstraZeneca, Bayer, Bracco, General Electric, Intermun, Merck, Novartis, Pfizer, PneumRx, PulmonRx, ROX, Essex (Schering-Plough), Siemens, Roche, Wyeth, and ZLB Behring and has been a consultant for AstraZeneca, Basilea, Baxter, Bracco, Essex (Schering-Plough), Systema, Gilead Sciences, Pfizer, Perceptive, Phillips, and Siemens.  Herbert Hof has been a consultant for Gilead Sciences and MSD and has served on the Speakers’ Bureau for Gilead Sciences, MSD, Pfizer, and Essex (Schering-Plough).  Michael Kiehl has been a consultant for Gilead Sciences and Essex (Schering-Plough) and has served on the Speakers’ Bureau for Gilead Sciences, MSD, and Essex (Schering-Plough).  Gloria Mattuizzi has received research support and grants from Astellas, MGI Pharma Inc., and Novartis.

Nursing Implications

Many of the interventions discussed were aimed at minimizing invasive fungal and other infections in patients, primarily neutropenic, who presented with lung infiltrates.  The pre-emptive B-II recommendation for antifungals lacked the strength of randomized, controlled trials.  The recommendation for intensive care to improve outcomes does not really address the prevention of infection.

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Maschio, M., Dinapoli, L., Sperati, F., Pace, A., Fabi, A., Vidiri, A., . . . Carapella, C.M. (2012). Effect of pregabalin add-on treatment on seizure control, quality of life, and anxiety in patients with brain tumour-related epilepsy: A pilot study. Epileptic Disorders, 14, 388–397. 

Study Purpose

To evaluate the effect of pregabalin as an add-on therapy on seizure control, quality of life, and anxiety in patients with brain tumor–related epilepsy.

Intervention Characteristics/Basic Study Process

Pregabalin was added as a first or second add-on drug at 75 mg/day to a maximum of 600 mg/day for specific drugs (i.e., clobazan, lamorigine, levetiracetam, oxcarbazepine, phenobarbital, valproate, and topiramate).

Sample Characteristics

  • N = 25 (final sample); 12 patients completed six-month follow-up
  • AGE RANGE: 19–72 years
  • MALES: 72%, FEMALES: 28%
  • KEY DISEASE CHARACTERISTICS: Patients with brain tumor–related epilepsy
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with brain tumor–related epilepsy who had received standard antiepileptic drugs (AED) and who had at least one seizure in the month preceding recruitment  despite AEDs being at the maximum tolerable dose

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Center for tumor-related epilepsy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Descriptive

Measurement Instruments/Methods

  • Quality of Life in Epilepsy Inventory
  • Quality of Life in Cancer
  • Hamilton Anxiety Rating Scale
  • Zung Self-Rating Depression Scale
  • Karnofsky Performance Status
  • Seizure diary

Results

The mean dose of pregabalin was 279 mg/day, and the mean follow-up period was 4.1 months. At the end of the follow-up, in the whole intention-to-treat population, nine patients were seizure free, 10 patients had a seizure reduction, and two patients were unchanged. There was a significant difference in the presence or absence of seizure between the baseline and the follow-up visit. There was a significant decrease in anxiety score (p = 0.002) between baseline and last available follow-up visit.

Conclusions

The study showed improvement in anxiety scores with pregabalins, but this is a pilot study with small sample size and a short follow-up period. Future studies with larger sample size and minimum dropout are indicated.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition) 
  • Findings not generalizable
  • Questionable protocol fidelity
 

Nursing Implications

Larger sample size is needed to evaluate the true impact of pregabalin on anxiety among patients with brain tumor–related epilepsy. There are not many implications for nursing because the intervention is drug related.

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Mar Fan, H. G., Clemons, M., Xu, W., Chemerynsky, I., Breunis, H., Braganza, S., & Tannock, I. F. (2008). A randomised, placebo-controlled, double-blind trial of the effects of d-methylphenidate on fatigue and cognitive dysfunction in women undergoing adjuvant chemotherapy for breast cancer. Supportive Care in Cancer, 16, 577–583.

Study Purpose

To investigate the effects of d-methylphenidate (d-MPH) on fatigue and cognitive function in women undergoing adjuvant chemotherapy for early breast cancer.

Intervention Characteristics/Basic Study Process

Patients were given 5 mg of placebo for the first chemotherapy cycle to assess for compliance and were then randomized to either d-MPH 5 mg twice daily (BID) or matched placebo. The dosage increased to 10 mg BID after one week and was taken in the morning and at noon.

Sample Characteristics

  • The sample was comprised of 57 women with breast cancer.
  • Median age was 50 years. 
  • Of the patients, 29 received d-MPH and 28 received placebo.
  • Patients were eligible for the study if they were receiving four cycles of standard adjuvant chemotherapy.

Setting

  • Multisite
  • Three hospital outpatient clinics in Toronto, Canada

Study Design

The study was a randomized, controlled trial with a placebo arm.

Measurement Instruments/Methods

  • High Sensitivity Cognitive Screen (HSCS)
  • Hopkins Learning Test–Revised (HLT-R)
  • Functional Assessment of Cancer Therapy–General (FACT-G)
  • FACT–Fatigue (FACT-F) 
  • Mini-Mental State Examination (MMSE)

All were measured at baseline, end of chemotherapy, and at six-month follow-up.

Results

The difference between groups was not significant in cognitive function or fatigue.

Conclusions

The findings do not support the effectiveness of d-MPH at the doses given here in reducing fatigue during active treatment for breast cancer.

Limitations

  • The study had a small sample size, with less than 100 patients. 
  • The study was underpowered; no trends suggest that d-MPH taken concurrently with adjuvant chemotherapy improves quality of life or fatigue.

Nursing Implications

D-MPH cannot be suggested as an intervention to relieve cancer-related fatigue or cognitive functioning.

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