To determine if the use of aloe and mild soap versus mild soap (Dove) alone would decrease the incidence of skin reactions. Aloe gel included aloe vera, triethanolamine, d-α tocopherol (natural Vitamin E), carbomer, tetrasodium ethylenediaminetetraacetic acid (EDTA), methylparaben, and imdazolidinyl urea.

Participants were randomized to use aloe vera gel and mild soap or mild soap alone. The skin care regimen began on the first day of treatment. Aloe was to be applied liberally after treatment each day, reapplied throughout the day, and rinsed off prior to treatment (no time frame identified). Assessments were performed on day 1 and in weekly reviews. Clinicians could order supplemental skin products as they deemed necessary.

• The sample was comprised of 70 patients (34% male, 48% female).
• Age was: 45 years (18% in each study group), 45–59 years (55% aloe/soap; 32% soap alone), and older than 59 years (27% aloe/soap; 50% soap alone).
• Patients had cancer of the head and neck (39%), chest (58%), and extremities (3%).
• Mean cumulative dose was 2,700 cGy (range 900–7,209 cGy) for aloe/soap and 2,838 cGy (range 1,080–5,580 cGy) for soap.

Comprehensive Cancer Centre, University of Miami

The study was a prospective, randomized, blinded clinical trial.

• Weekly skin scoring was performed with Radiation Therapy Oncology Group (RTOG) acute criteria. 
• Other skin changes, such as texture, were recorded; there was no description of how these were assessed or measured.

The only significant difference found was delayed time to observation of a skin change with aloe in those with a cumulative dose greater than 2,700 cGy (p = 0.01).

No clear benefit of aloe vera was demonstrated.

• It was unclear if all assessments were made at the same dose intervals or only once weekly.
• Clinicians could order supplemental skin products as needed based on scoring severity of skin reactions. It was not possible to determine if the effect was related to aloe or other products.
• There was no documentation of skin reactions other than erythema or start to skin changes.
• No measures were described for the only significant finding.
• Patients were assessed weekly using RTOG, but no RTOG scores data were provided.
• The research question was “would aloe/soap decrease the incidence of skin reactions,” but the study was designed to assess delay to erythema. Data were not provided regarding overall incidence.
• There was a wide range of doses.
• Study conclusions stated were not supported by any data.
• The author stated the study was double-blind; however no control product was identified or discussed.

To evaluate the efficacy of Paullinia cupana in decreasing the number and severity of hot flashes in breast cancer survivors

The intervention consisted of 50 mg of dry extract of Paullinia cupana taken orally twice per day for six weeks. If patients presented unacceptable side effects, the intervention was stopped or the patient was removed from the study. All patients were trained to record each hot flash from a week before the initiation of the study until the sixth week. Severity was classified using published reports. The moments that were recorded took place at beginning of week 2 and then weekly until week 6. During each visit, patients' diaries were reviewed to check the severity of symptoms.

• N = 15  
• AGE RANGE = 36–65 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors undergoing hormonal treatment at least three months after chemotherapy or radiotherapy treatment
• OTHER KEY SAMPLE CHARACTERISTICS: May be on aromatase inhibitors or tamoxifen; must be having > 14 hot flashes per week

• SITE: Not specified
• SETTING TYPE: Not specified
• LOCATION: Brazil

• PHASE OF CARE: Transition phase after active treatment

Phase-II pilot study without a control group

• Diaries with self-reported scores were used by patients.
• The number and severity of hot flashes was scored from 1 (mild) to 4 (severe).

Of the 15 patients, 10 had a significant decrease greater than 50% in hot flash severity scores (p < .0001). The results demonstrated a statistically significant decrease in the number of hot flashes experienced by participants (p = .0009).

Although the authors reported a statistically significant decrease in the number and severity of hot flashes with the intervention of Paullinia cupana, there are many concerns regarding this study. The safety and purity of Paullinia cupana need to be established prior to recommendations of use.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group) 
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Measurement/methods not well described
• Measurement validity/reliability questionable 
• Findings not generalizable
• Other limitations/explanation: In using a supplement that is not tested for purity and safety, many variables cannot be proven. Adherence to interventions could be compromised.

It is important to be aware of a supplement (Paullinia cupana) that has been reported to decrease hot flashes in women after breast cancer treatment. Nurses also need to understand that this supplement has not been tested by the U.S. Food and Drug Administration, so the contents of this supplement cannot be proven. This study does not report any adverse effects from the agent; however, caffeine is known to be associated with adverse side effects.

Databases searched were PubMed, PsycINFO, CANCERLIT, and Cochrane Library through May 2003.

Twelve randomized trials were included. Nonrandomized trials, pilot studies, and studies in which exercise was combined with other therapies, such as cognitive therapy or diet, were excluded.  Outcomes were fatigue, health-related quality of life, physical exercise capacity (maximal oxygen consumption), and other physical performance measures.  Treatment evaluated aerobic exercise training (10 studies) and resistance exercise (two studies).

• Sample sizes ranged from 21 to 155 patients.
• Nine studies included breast cancer patients, most of whom were stages I or II. The remaining studies included samples with mixed diagnoses, prostate cancer, and acute leukemia.
• In 10 of 12 studies, the intervention was conducted when patients were undergoing radiation therapy and/or chemotherapy treatment; two trials implemented exercise after the treatment was finished.
• Eleven of 12 studies were performed in patients receiving treatment with curative intent, and one study included a mix of patients receiving treatment with either curative or palliative intent.

Three studies reported a significant reduction in fatigue. One study observed a significant reduction in fatigue, although this did not reach statistical significance. In another study, no statistical analyses were performed to examine between-group differences.

The reviewed studies indicated promising effects on both physiological and psychological outcomes. However, the reviewed studies differed widely in the length of the exercise program, its intensity, content, and frequency, and the timing of the interventions in relation to the patient’s disease and treatment.

• In many of the studies reporting data on quality of life, too many outcomes were listed (range 2–12), and only four of the trials defined which variables were the primary endpoints.
• Randomized clinical studies are few, small in scope, and focus mainly on patients with breast cancer.
• Complete knowledge about the type of physical exercise most beneficial for patients at different stages of disease is lacking.

Future exercise intervention studies should also identify fewer and more specific endpoints.

To test the hypothesis that physical exercise reduces fatigue and improves physical performance in patients with advanced cancer.

Patients were randomly assigned to physical exercise (PE) or usual care (UC) groups. The PE group had two exercise sessions per week that lasted 50 to 60 minutes after a 10-minute warm-up. Exercise was performed in groups of two to eight and was supervised by a physiotherapist. Sessions included circuit training and stretching/relaxation. Focus was on muscle strength, balance, and aerobic endurance. Pre- and postintervention were performed at baseline at immediately after the intervention period.

• In total, 231 patients (62.3% female, 37.7% male) were included. 
• Mean age was 62.4 years (range 24–86). 
• Multiple types of cancer in advanced stage were included.
• Of the patients, 55% were receiving chemotherapy and 75% had a Karnofsky Performance Status score of 80 or greater.
• Of the patients, 65% had a baseline low level of activity of less than one hour per week.

• Multi-site
• Norway

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

This was a randomized, controlled trial.

• Fatigue questionnaire
• Physical activity prior to the study (none, <1 hour/week, 1-2 or 3 hours/week)
• Motivation (0-10 numerical scale)
• Physical performance tests: sit-to-stand, grip strength, maximal step length (balance), and shuttle walk (how far and fast one can walk) tests

Median survival times for all included patients were 11.1 months in the PE group and 12.3 months in the UC group. In the PE group, exercise adherence was 69% on average (11 of 16 sessions).  Regression analysis showed no significant between-group effect in physical fatigue (estimated mean difference = -0.3; confidence interval [-1, 1.0]; p = 0.62).  There were significant differences between groups in shuttle walk test (p = 0.008) and grip strength (p = 0.01) results. There were no apparent effects of the exercise intervention on mental or total fatigue, including mental and physical fatigue.

Findings showed that such an exercise program is feasible in patients with advanced disease and limited life expectancy. Findings did not provide support for the hypothesis that exercise reduces fatigue in this group of patients.

• The study lacked an appropriate control group.
• In the PE group, 35.5% of patients were lost to follow-up predominantly due to disease progression.

Exercise programs are feasible for patients with advanced disease. Study findings did not show that the intervention improved the symptom of fatigue, but it did improve some physical performance.

To test the effect, on pain severity and interference with daily life, of standard care versus care supplemented with pain education

Patients were referred by primary care providers and randomly assigned to the pain education program or standard care. The education intervention was provided in clinics and by telephone. Intervention included enhancing knowledge about pain and pain treatment.  Patients were contacted weekly by telephone. During each call they reviewed pain outcomes and side effects and received reinforcement education as necessary. In the report of the study, authors did not described standard care. The study was conducted over eight weeks. The study was originally designed to evaluate three groups; however, because of low recruitment the study compared only two interventions.

• The sample was composed of 59 patients. 
• Mean patient age was 59 years (SD = 11 years).
• Of all patients, 35% were male and 65% were female.
• The sample included patients with various tumor types; 82% of patients had metastatic disease.
• Average duration of pain was five months. All patients had nociceptive pain.
   

• Single site
• Outpatient
• Rotterdam, the Netherlands

Phases of care: multiple phases of care

Randomized controlled trial

• Brief Pain Inventory
• World Health Organization analgesic ladder (step scale)
• Pain management index
• Medication Event Monitoring Systems (MEMSs)
   

Average reduction in pain intensity declined in both groups. The decline was 0.8 (20%) greater in those receiving the intervention program (p = 0.03) than in those receiving standard care. Pain-related interference declined more in the intervention group (p < 0.01).  In the group that received the intervention, the percentage of patients who received both round-the-clock and as-needed medication increased: Of those receiving the intervention, 88% changed to this approach. In the group receiving standard care, 50% changed to the approach (p = 0.003). Adherence was initially the same across both groups. In the last two weeks, however, adherence was 74% in the standard-care group and 85% in the intervention group (p = 0.028).

The educational and support intervention was associated with greater decline in pain severity and pain-related interference, more aggressive pharmacologic management, and slightly better patient adherence over an eight-week period.

• The study had a small sample, with fewer than 100 participants.
• The study had a risk of bias due to no blinding.
• Authors noted that the study was underpowered.

Findings from this study support evidence that psychoeducational interventions can improve pain management and pain outcomes in patients with cancer-related pain. Incorporating such interventions and related follow-up programs into nursing practice can greatly benefit patients with chronic pain.

To describe the analgesic efficacy and side effects of parenteral hydromorphone among patients with severe cancer-related pain

Medical records were reviewed and data were collected retrospectively for patients admitted to a palliative care unit for pain management because of uncontrolled pain or severe side effects from their current pain regimens. Patients were started on parenteral hydromorphone. After starting the intervention, pain intensity and side effects were recorded twice daily. All patients had previously received opioids.

• N = 104      
• MEAN AGE = 57 years (SD = 13.5 years)
• MALES: 55%, FEMALES: 45%
• KEY DISEASE CHARACTERISTICS: 88% had metastatic disease and nociceptive pain
• OTHER KEY SAMPLE CHARACTERISTICS: Some patients were receiving chemotherapy or palliative radiation therapy. Some patients also were receiving ketamine during the study. Eighty-eight percent had had two or more previous opioid rotations. Median effective dose was 600 mg per day (range = 72–2592 mg per day).

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

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

• Retrospective, descriptive

• Numeric rating scale for pain
• Effectiveness determined as change in mean pain intensity at rest and with movement
• Time of adequate control was defined as first of at least two consecutive days with mean pain score of 4 or less, or physician was satisfied that pain was controlled

Adequate pain control was reported for 83% of patients, and among those who had improvement, the decline in mean pain score was significant (p < .001), ranging from a 2.7–3.1-point reduction. Seventeen percent had no response. Survival analysis showed continued effect of hydromorphone for 150 days for those who continued on the study (35 patients).

Switching to parenteral hydromorphone was effective for pain control in some patients who had either uncontrolled pain or severe side effects with previous pain medication regimens.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• 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
• Other limitations/explanation: Differences in pain scores were used to show statistical significance, but the timing of measures used is not described, and authors state that where measurements were not available, physician satisfaction with control was used to show efficacy. It was stated that some patients were on ketamine, but it was not clear how much, who, or the potential impact on findings. A variety of coanalgesics were used, with no relevant subgroup analysis. There was extreme variability in baseline opioid dosages, suggesting highly varied baseline pain levels as well–range of baseline levels is not provided. Some patients also were receiving other palliative therapies, and analysis did not consider this.

Findings suggest that opioid rotation to parenteral hydromorphone was effective for some patients who had either uncontrolled pain or unacceptable opioid side effects. This study provides rather weak evidence because of numerous study limitations, but, for those patients at the end of life with intractable pain or significant adverse effects on current pain regimens, alternative approaches that may be effective are important to consider. Parenteral hydromorphone may be an appropriate alternative for these patients.

STUDY PURPOSE: To review the safety and efficacy associated with triple therapy (aprepitant, ondansetron, and dexamethasone) when given to children and adolescents receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC)

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 3
• TOTAL PATIENTS INCLUDED IN REVIEW = 451
• SAMPLE RANGE ACROSS STUDIES: Unknown
• KEY SAMPLE CHARACTERISTICS: Aged 0.5–19 years; common diagnoses included bone cancers (Ewing sarcoma, rhabdomyosarcoma, and Hodgkin lymphoma).

Triple therapy with aprepitant, dexamethasone, and ondansetron had a 52% relative risk reduction in the development of chemotherapy-induced vomiting, and febrile neutropenia was not significantly different in patients receiving triple therapy compared to patients receiving dual therapy.

Triple therapy may reduce chemotherapy-induced vomiting in pediatric patients receiving MEC and HEC.

Pediatric patients receiving MEC and HEC may benefit from receiving triple therapy (aprepitant, ondansetron, and dexamethasone) for the prevention of chemotherapy-induced vomiting.

To evaluate the effectiveness of goshajinkigan (GJG) in reducing peripheral neurotoxicity in patients receiving FOLFOX for colorectal cancer

Patients with colorectal cancer were randomized to receive either GJG 7.5 mg three times daily or placebo in a double-blind manner. The time to grade 2 or higher neuropathy was the primary endpoint.

• N = 155 (of planned 310)   
• MEAN AGE = 62.4 years (GJG), 60.4 years (placebo)
• MALES: 53.9% (GLG), 54.8% (placebo); FEMALES: 46.1% (GLG), 45.2% (placebo)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All patients had stage III colorectal cancer. All patients had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Most patients had no comorbidities.
• OTHER KEY SAMPLE CHARACTERISTICS: Creatinine clearance greater than 60 in 86.5% of patients receiving GJG; 90.3% of patients receiving placebo

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

PHASE OF CARE: Active antitumor treatment

Double-blind, placebo-controlled, randomized study

Time to grade 2 or higher neuropathy as described by Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, and the DEB-NTC. Standardized questions regarding symptoms of neurotoxicity and examples of answers were used to facilitate accurate classification and grading of symptoms. Grades were determined by physicians and were documented in patient records.

A total of 142 patients were evaluable. Incidence of grade 1 peripheral neuropathy was 43.8% in the GJG group and 62.4% in the placebo group; incidence of grade 2 or higher was 50.6% in the GJG group and 31.2% in the placebo group. Time to development of neuropathy was also significantly less in the GJG group (p = 0.007). GJG did not reduce time to neuropathy even for grade 1. Adverse events other than neuropathy showed no difference between the two groups. Secondary endpoints of dose intensity and treatment cycle were higher in the GJG group (not significant).

GJG did not decrease the time to grade 2 neuropathy; in fact, it seems to have hastened development. There was some effect on the dose intensity and treatment cycle given, but this was not a significant difference.

• Key sample group differences that could influence results
• The study stopped early because of findings that it was not effective in the manner theorized.

A total of 155 patients in each arm were planned, but after a total of 155 patient enrolled, an interim analysis was performed and the study was stopped at that time because of findings that GJG was not as effective as hoped. Nurses must ask patients medications, including all supplements, to educate patients on potential interactions and potential harm from supplemental medications. This is marketed in Japan for treatment for diabetic neuropathy but does not seem to be effective for chemotherapy-induced neuropathy, and education of patients is key.

STUDY PURPOSE: To examine nonpharmacologic intervention effects on cognitive function in adult survivors of cancer, and to examine whether these effects are driven by psychological or behavioral intervention types

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 14 systematic reviews,11 meta-analyses
• TOTAL PATIENTS INCLUDED IN REVIEW = 977
• SAMPLE RANGE ACROSS STUDIES: 13–157 patients 
• KEY SAMPLE CHARACTERISTICS: The mean age was 53.1 years. Cancer diagnoses were breast (n = 7), glioma (n = 3), mixed diagnoses (n = 3), and hematologic (n = 1). Stage not mentioned (n = 4), stage I–III (n = 7), all stages (n = 3)

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Eleven studies used psychological interventions, and three used behavioral interventions. All studies used standard care control groups, with intervention durations of two weeks to more than one year that included an average of 16 one-hour sessions. Psychological interventions used individual-based cognitive rehabilitation (n = 10) with three using computer-based retraining programs. Outcomes included subjective cognitive function (n = 5), attention (n = 6), memory (n = 8), executive function (n = 7), verbal ability (n = 3),  and multiple domains (n = 7). Low risk bias assessments: Rrandomization (n = 5), allocation concealment (n = 3), blinded participants or personnel (n = 2), blinded personnel conducting outcome assessment (n = 4), attrition (n = 12), reporting bias (n = 14), monitoring procedures, and manual use (n = 13). Statistical heterogeneity ranged from none to moderate (I² = 0%–68%). Significant treatment effects existed for nonpharmacologic interventions on memory (n = 8, d = 0.21, 95% confidence interval [CI] [0.04, 0.38], p = 0.02, I² = 0%) and perceived cognitive function (n = 5, d = 0.41, 95% CI [0.2, 0.61], p < 0.001, I² = 0%). Subgroup analysis for psychological interventions was significant for effect on perceived cognitive function (n = 3, d = 0.35, 95% CI [0.13, 0.58], p = 0.002, I² = 0%).

The treatment effects of nonpharmacologic interventions significantly improved memory and perceived cognitive function. The meta-analysis indicated that psychological interventions significantly improved perceived cognitive function. No treatment effects from other interventions were observed, and no effects on cognitive performance in domains of executive function, attention, and verbal ability were observed. Most studies reviewed in this meta-analysis did not provide sufficient evidence to demonstrate improvement in cognitive performance. Further study is warranted using RCT designs to increase the sample pool to observe positive treatment effects.

• Limited number of studies included
• Low sample sizes

Nonpharmacologic interventions, specifically those involving psychological interventions, have demonstrated improvements in memory and self-reported cognitive function in adult survivors of cancer.

To examine the effects of medical qigong on self-reported cognitive function in patients with cancer

Participants were randomized to 10 weeks of medical qigong or usual care. Self-reports of cognitive functioning were evaluated at baseline and at the conclusion of the 10-week intervention. The medical qigong program was a weekly 90-minute group class that included a 15-minute discussion of health, 30 minutes of gentle stretching and body movement in a standing position, 15 minutes of movement in a sitting position, and 30 minutes of meditation and breathing. Two sessions were offered each week; participants could attend one or both of the sessions but had to attend for a minimum of 7 of the 10 weeks. Participants also kept a diary.

• The total number of participants randomized was 81. Fifty-four completed the study, resulting in a 33% drop out rate.
• Participants' mean age was 62 years (SD = 12 years), with a range of 34–86 years.
• The sample was 50% male and 50% female.
• N = 25, colorectal 12%, lung, prostate, gastric, other   
• Forty-two participants received adjuvant treatment, and 36 were receiving metastatic treatment.
• Forty-eight participants completed chemotherapy, and 28 were receiving chemotherapy at the time of the study.
• On average, participants had completed 16.4 years of education (SD = 2.1).
   

• Mutli-site
• Outpatient setting
• University hospitals in Sydney, Australia
   

• Patients were currently undergoing treatment or had completed treatment.
• The clinical applications are for late effects and survivorship.
   

The study was a stratified, randomized controlled trial of a subset of patients from a larger study.

• European Organization for Research and Treatment of Cancer–Quality of Life (EORTC QLQ)–c30, CF version 3 (two items on the cognitive subscale)
• Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog)
   

Participants in the intervention group showed significant improvement in perceived cognitive functioning on both the EORTC QLQ-C30  (p = 0.014) and FACT-Cog  (p = 0.029) compared to the control group (usual care) over time at 10 weeks' follow-up.

Results suggest that medical qigong may improve patients' perception of their cognitive functioning. However, further studies are needed with a larger sample size, objective measures, and longer follow-up to determine whether results are sustainable.

• The sample size was less than 100.
• The 33% drop-out rate was significant.
• Cognitive functioning was self-reported and was not the primary endpoint.
• Attentional control was not used.
• The study was not blinded and therefore had an associated risk of bias.
   

The study suggests that qigong may be beneficial in improving cognitive function in patients with cancer. However, the drop-out rate was significant at 33%. Drop outs occurred for multiple reasons, but it shows that qigong may not be a realistic intervention for some patients with cnacer. Further studies on the specific impacts qigong has on cognitive ability need to be conducted.