To describe the clinical effectiveness of a particular device in decongestive therapy

The Schnogh device consists of fabric and other parts that enable a spiral twisting that delivers sequential compression for 15 minutes followed by decompression for five minutes over the course of an hour. Patients analyzed in this study completed five days of treatment over one week.

• N = 647
• MEAN AGE = 56 years (range = 6–82 years)
• MALES: 12%, FEMALES: 88%
• KEY DISEASE CHARACTERISTICS: Varied causes of primary and secondary limb lymphedema for upper or lower limbs were included. Among participants, 95% of those with arm lymphedema had breast cancer, and 53.8% of those with lower limb lymphedema had cervical, uterine, or ovarian cancer.

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

• APPLICATIONS: Pediatrics

Prospective, descriptive study

• Limb circumference for calculated limb volume

The average percent limb volume reduction was 50.2% for upper extremities and 55.6% for lower extremities.

Decompression therapy as provided with the device described here was effective in reducing lymphedema volume.

• Risk of bias (no control group)
• Risk of bias (no random assignment)

Complete decongestive therapy is effective for lymphedema reduction with most evidence describing its use in upper extremities. The findings in this study suggested that this device can provide similar results with no manual decongestive component. Additional well-designed studies are needed to confirm that this approach yields comparable or better results than current treatments.

To evaluate the safety and efficacy of olanzapine for breakthrough emesis in addition to standard antiemetic regimen in patients with cancer receiving highly emetogenic chemotherapy

All patients were treated with the institutional standard for HEC: ondansetron 24 mg IV BID and dexamethasone 10 mg IV BID on day 1. Oral metoclopramide 10 mg TID plus dexamethasone 10 mg po BID were given on days 2 and 3. Oral olanzapine 5 mg was given after the first vomiting episode. Twelve hours later, the second dose was given concurrently with the standard prevention regimen. 

• N = 46  
• AGE: 89.1% younger than 50 years, 10.9% were 50 years or older
• MEDIAN AGE = 33.5 years 
• MALES: 69.5%, FEMALES: 30.5% 
• KEY DISEASE CHARACTERISTICS: Patients with solid tumors to receive at least one cycle of chemotherapy. No nausea or vomiting reported for at least 12 hours prior to chemotherapy 

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Khon Kaen, Thailand

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care 

• Phase II prospective open-labeled clinical trial

• CINV measured by the Index of Nausea, Vomiting, and Retching (INVR tool) every 12 hours. Adverse drug reactions were evaluated by using the Naranjo’s algorithm to estimate the occurrence probability. CTCAE V. 4.03 was used.

Complete response of breakthrough emesis was 60.9%, retching was 71.7%, and nausea was 50.0%. Adverse events were mild, including dizziness, fatigue, and dyspepsia. 

The study demonstrated the effectiveness and safety of olanzapine in the treatment of nausea and vomiting in HEC patients. Olanzapine could be considered for treatment of patients at high risk for breakthrough emesis despite standard prevention. Olanzapine 5 mg every 12 hours for at least 24 hours could be recommended per the study.

• Small sample (< 100)
• Risk of bias (no control group)
• Other limitations/explanation
  • The “standard antiemetic” is not recommended by NCCN, ONS, MASCC, and ASCO for HEC.   
  • The medications used in the delayed phase were not recommendations by NCCN, MASCC, ONS, and ASCO guidelines.   
  • Olanzapine was only used for 24 hours at 5 mg (2 doses). Other olanzapine studies and guidelines recommend 3 days at 10 mg. 

Olanzapine is a drug that could be extremely helpful in treatment of CINV. Studies have shown olanzapine to be a safe and effective medication in acute and delayed CINV. The reviewed study attempted to show effectiveness in the breakthrough setting but many limitations were reported and are listed above. The researchers should not conduct CINV studies for “breakthrough” if the patient is given suboptimal treatment upfront.

To evaluate the effectiveness of transdermal fentanyl (TF) for pain management in patients with head and neck cancer receiving radiotherapy; to evaluate the effectiveness, safety, and long-term tolerability of TF after initial administration

Patients entered in the trial were instructed in the use of TF. Initial TF dose was 25 mcg/hour, and patches were replaced every three days. Dose was titrated upward as needed, in 25 mcg/hour increments. Patients requiring more than 50 mcg/hour were allowed to use multiple patches to achieve the required dose. Doses greater than 100 mcg/hour were used in exceptional circumstances only. As a treatment for breakthrough pain, patients received immediate-release morphine to be administered as needed, every 2–4 hours. Use of all rescue medications was recorded. Pain was measured by means of a questionnaire that was administered at study entry and after 7, 14, 28, 35, and 42 days. Amount of rescue analgesics and data about constipation, diarrhea, and use of laxatives and antidiarrheals were recorded by patients daily. Investigators summarized the data at each study visit.

• Initially, the sample was composed of 163 patients. The size of the sample at the end of the study was 108 patients.
• Mean patient age of the final sample was 53 years. Age range was 24–68 years.
• Of all patients, 9.2% were female and 90.8% were male.
• All patients had head and neck cancer and were receiving radiation therapy. Most were taking nonsteroidal anti-inflammatory drugs, codeine, and tramadol. Of all patients, 11% were taking morphine at the time of study entry, and 57.7% were receiving chemotherapy. The average radiation dose over 42 days was slightly under 7000 cGy. Initial pain scores for 44.2% of patients were equal to or greater than 7.

• Multisite
• Outpatient
• Taiwan

Prospective trial

• Visual analog scale (VAS), to measure pain
• Wisconsin Brief Pain Inventory (BPI), short version, to measure pain
• Five-point Likert scale (0 = fully awake, 4 = drowsy most of the time), to measure daytime drowsiness
• Five-point Likert scale (0 = no symptoms), 4 = very severe), to measure nausea or vomiting
• National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3, to measure adverse effects

• The most commonly used dose of TF was 25 mcg/hour at days 0, 7, 14, 21, and 28.
• Of patients treated by radiotherapy alone, 7% received a dose of TF that was larger than 25 mcg/hour. Of patients who also received chemotherapy, 34.8% required a dose larger than 25 mcg/hour.
• VAS pain scores declined in all patients, but authors reported no statistical significance. By day 42, VAS scores indicated no further decline in pain.
• Scores in each domain of the BPI improved after one week and on days 7 (p < 0.05) and 28 (p < 0.0001). BPI scores improved significantly.
• Of patients in the initial sample, 55 patients (34.4%) had dropped out by the second week of treatment. They dropped out because of side effects. Twenty additional patients (12.3%) did not complete the study because of interruption of radiotherapy due to sepsis, the fact that TF was no longer needed, grade 3–4 vomiting (23.9%), nausea (16.6%), somnolence (4.9%), or dizziness (4.9%)

Data suggest that TF can be effective and relatively easy to use, in an outpatient setting, for patients receiving radiotherapy; however, TF was accompanied by a high rate of severe side effects.

• The study had a risk of bias due to no appropriate control group.
• The study had a very high dropout rate due to side effects.
• Authors provide no statistical analysis over time of VAS score changes or other score changes.
• The reported findings related to side effects were confusing. Authors stated that, initially, 55 patients dropped out due to side effects and that another 20 patients did not complete the study. The actual prevalence and severity of side effects is unclear.

Additional research regarding various approaches to pain management, in the cited population, is needed.

STUDY PURPOSE: To review the current literature regarding the treatment of lymphedema, providing applications of the evidence to the care of patients with cancer, with or at risk for, lymphedema

PHASE OF CARE:  Multiple phases of care

The PAL trial provides the strongest evidence to date that progressive resistive exercises may reduce the risk of, and not exacerbate pre-existing,  BCRL. However, no clear evidence-based recommendation regarding compression garment use during exercise can be made. Surgical treatment is associated with risk, and should not be considered a first line treatment.  IPC devices may play a role in a multi-modality approach.  There are no clear evidence-based guidelines for pressure setting use in lymphedema management.

CDT remains the standard in LE therapy, but there is some limited evidence supporting consideration of adjunctive therapies, such as exercise, surgery, and IPC. More RCTs looking at exercise and LE in populations other than those with breast cancer are needed, especially studies with LE of other areas of body, and role of compression garments during exercise. Surgical treatments are promising in LE not responsive to standard therapy. IPC in low to moderate pressure ranges appear to be a safe adjunctive treatment option for appropriate, selective patients, in conjunction with CDT.

• Exercise studies were limited to BCRL. 
• Surgical studies need larger cohorts. 
• Longer follow-up was needed. 
• IPC studies are needed evaluating cost benefit, as well as specific recommendations, for pressure settings and length of treatments.

Patients with LE need education regarding the benefits of exercise in general health and cancer prevention, tailored to their individual needs and comorbidities. Surgery for LE should not be considered a first-line treatment. Microvascular procedures should be treated by experienced surgeons offering ongoing care with support from certified lymphedema providers. IPC is potentially a valuable adjunctive therapy, and should be prescribed only by practitioners trained at a specialist level. With no clear guidelines for use, the authors recommend the current NLN recommendations for pump pressures from 30-60 mmHG. Additional research is essential in these categories to provide evidence based guidelines and safe, effective patient care for patients with lymphedema.

STUDY PURPOSE: To review the published evidence on non-pharmacologic interventions for fatigue in children and adolescents with cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: Cochrane Library, Joanna Briggs Institute Library of Systematic Reviews, CINAHL, PsycINFO, Ovid, MEDLINE, ProQuest Dissertations and Theses, the Electronic Theses and Dissertations System, the Index to Taiwan Periodical Literature, Electronic Thesis and Dissertation System (Chinese)

KEYWORDS: experimental study, random study, quasi-experimental study, children, adolescents, pediatric, cancer, oncology, nonpharmacological interventions, massage, exercise, fitness, physical activity, cognitive-behavioral, stress management, energy conservation, sleep therapy, relaxation, distraction, psychoeducation, fatigue, cancer-related fatigue, loss of energy, levels of tiredness, tired, side effect, symptoms

INCLUSION CRITERIA: RCT or quasi-experimental studies; 1–18 years of age, experiencing cancer-related fatigue; maintenance stage or survivor stage; hospitalized or home; acute lymphoblastic leukemia (ALL)/acute myeloid leukemia (AML)/lymphoma/solid tumor; interventions with descriptions of length, frequency setting, and provider, and including activity enhancement, psychosocial interventions, cognitive behavioral therapy, stress management, relaxation, nutrition consultation, massage, or educational interventions; use of validated scales for cancer-related fatigue in outcomes

EXCLUSION CRITERIA: Written in languages other than English or Chinese

TOTAL REFERENCES RETRIEVED = 76

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Retrieved papers reviewed by two independent reviewers with a third for disagreements about methodologic validity

• FINAL NUMBER STUDIES INCLUDED =  6, 3 in meta-analysis
• SAMPLE RANGE ACROSS STUDIES: 9–60
• TOTAL PATIENTS INCLUDED IN REVIEW = 149
• KEY SAMPLE CHARACTERISTICS: Outpatient and hospitalized children; ALL, solid tumor, AML, and lymphoma; ALL most common; varied disease stage; range from first cycle of chemo to survivor; five studies in the United States, one in Taiwan; home, community, and hospital setting; interventions of exercise-training, physical activity, massage, health education, and exercise training

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Pediatrics

Two studies showed no significance in decreasing total fatigue with exercise. Two studies suggested exercise reduced general fatigue (p < .01). No significance was found for sleep/rest fatigue or cognitive fatigue. Study of massage showed no effect on fatigue. Final study used nurse education session on fatigue versus UC with reports that interventions were “effective.”

No study reduced total fatigue in any population. General fatigue was the only fatigue measure with significant improvement in some studies.

The phases of care, tumor type, and age varied. Children may not have had an ability to differentiate fatigue and relaxation, making fatigue perhaps difficult to measure.

Exercise may be a safe intervention for improving general fatigue in children and adolescents experiencing cancer-related fatigue.

The study's primary aim was to evaluate the effect of epoetin alfa on changes in quality of life and utility scale scores at week 12. Its secondary aim was to evaluate transfusion reduction and hemoglobulin level increase.

Participants were screened at the initiation of chemotherapy with hemoglobin (Hgb) levels ≤ 15.0 grams per deciliter (g/dL). Randomization occurred when the Hgb level was decreased to 12.0 g/dL. They received 40,000 IU of erythropoietin subcutaneously each week for 16 weeks or for 4 weeks after the completion of chemotherapy, whichever was longer (the maximum amount of time participants could receive erythropoietin was 28 weeks).

• All participants were female and had breast cancer. 
• The number of participants was 354.
• There were 176 participants in the treatment gruop and 178 in the control group.
• The average participant age in the treatment group was 50.4 years, with a range of 27–85.
• The average participants age in the control group was 50.1 years, with a range of 27–85.

This multi-site study was conducted in Canada. 

The study was a phrase III, randomized, open-label, multi-center trial. 

• The Health Utilities Index Mark (HUI) measured eight components of quality of life, including cognition.
• The Functional Assessment of Cancer Therapy (FACT) - Anemia and Fatigue measured cancer-related quality of life specific to symptoms of anemia and fatigue.
• The Cancer Linear Analog Scale (CLAS) measured quality of life.
• The EuroQol 5-Dimension (EQ-5D) is a linear analog scale of 0–100, with 100 representing the best imaginable health. It is described as the use of a thermometer, known as a feeling thermometer.

Based on the subscale HUI survey, significant improvement in cognition (p = 0.02) was found in participants who received erythropoietin.

• Improvement in cognition was based on a subjective, not objective, measurement.
• Cognitive improvement may be independent of hematologic change, as it was not correlated with changes in Hgb level.

No objective measure for cognitive function was used.

To test whether participation in yoga during radiation therapy would have long-term effects on fatigue, depression, and sleep disturbances

Patients were randomly assigned to one of three groups: a yoga group, an exercise group, and a wait list control group. Yoga and exercise groups attended up to three 60-minute sessions per week during six weeks of radiation therapy. These were given one-on-one or in groups according to the patient’s convenience and schedule. Each received a CD and written program manual to encourage at-home practice. The yoga program included warm-up breathing, postures, deep relaxation, alternate nostril breathing, and meditation. The exercise program included exercises specifically recommended for women recovering from breast cancer treatment involving multiple positions and stretching. Study assessments were done at baseline, during the last week of treatment, and at one, three, and six months after treatment.

• N = 132  
• MEAN AGE = 52 (range = 26–79)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer, 64% also were on chemotherapy. Over 60% had breast-conserving surgery
• OTHER KEY SAMPLE CHARACTERISTICS: 16.5% were African American, 44% had at least some college education

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION:MD Anderson in Houston, TX

• PHASE OF CARE: Active anti-tumor treatment

• RCT with active control

• SF-36^®
• Brief Fatigue Inventory
• Pittsburgh Sleep Quality Index
• Centers for Epidemiological Studies–Depression scale
• Salivary cortisol levels

Greater increases in physical component scores of the SF-36 were seen in the yoga group compared to both other groups at one and three months (p = .01). The yoga group (p = .04) and exercise group (p = .02) had greater reduction in fatigue compared to wait list controls at the end of treatment. These differences were not significant at other time points. Fatigue consistently declined over time in all patient groups. Sleep quality improved in all groups over time with no significant differences between groups.

Both yoga and exercise were associated with reduced fatigue by the end of radiation treatment; however, these effects were not maintained over the following six months.

• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Almost 30% were lost to follow-up despite payment of participants for completion of each study assessment. Other interventions that may have influenced outcomes were not described. No intent to treat analysis. Baseline fatigue was low on average across all groups

Findings showed that both yoga and exercise programs during radiation therapy were beneficial in reducing fatigue. Fatigue declined over time in all patients, and effects seen by the end of treatment did not appear to last. The follow-up information here is limited by the high number lost to follow-up, showing the difficulty of conducting longitudinal examination of intervention effects. Nurses can recommend that patients participate in programs such as yoga and exercise during active cancer therapy.

TOTAL REFERENCES RETRIEVED: 8,599

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Risk of bias was assessed according to the Cochrane handbook

PHASE OF CARE: Active antitumor treatment

Forty-seven studies on the six types of interventions for managing RISR were reviewed (oral systemic medications, skin care practice [washing and deodorant], steroidal topical ointment/cream, dressings, nonsteroidal cream/ointment, and LED vs sham treatment). The results of a meta-analysis of Wobe Mugos versus a control showed an odds ratio of 0.13 (p < 0.0004) in favor of Wobe Mugos. There was a mean difference of -09/92 (p < 0.0001) for Wobe Mugos treatment across two studies including 219 patients. Pentoxifylline was not shown to have an effect. Oral sucralfate and oral antioxidants did not show an effect. Various topical steroids showed mixed results. A meta-analysis of trolamine showed no significant benefit. Washing the skin and using deodorants did not affect skin toxicity scores. Evidence was restricted because of the variation of interventions as it was not easily detectable which products would be most effective. There was no strong evidence for any of the products included in the study. The study quality of most of the included RCTs was only fair, and there were few interventions that were examined in multiple studies.

Additional research studies establishing the effectiveness of multiple skin care products is needed. The findings of this meta-analysis in regard to Wobe Mugos were positive, suggesting that additional, well designed research is warranted.

• Small number of studies per interventions for a meta-analysis
• Variation in products used
• No clear information on anatomical sites where the products were used

Additional research on skin care products used to manage RISR is needed.

To review the evidence for interventions to prevent and manage radiodermatitis.

Databases searched were MEDLINE, CIHANL, EMBASE, and Cochrane.  Key journals were manually searched.

The primary aim was to review the efficacy of interventions for preventing and managing radiodermatitis. The article was published in a peer-reviewed publication.

The following were excluded from the review:  unpublished work, abstracts, letters, and conference proceedings.
 

In total, 1,837 references were retrieved. Assessment of multiple systematic reviews (AMSTAR) was used.

• The final number of studies reviewed was 6 reviews and 107 total research studies.
• The sample range across studies was 5 to 39 patients.
• The sample mostly included patients with breast and head and neck cancers.

There is insufficient evidence to support the use of any particular intervention for preventing or managing radiodermatitis. There were several shortfalls identified in these systematic reviews. It was noted that the outcomes of pain, itching, and quality of life should be incorporated into the research in this area.

There was high variability in the quality of the systematic reviews concerning management and prevention of radiodermatitis.

The study was limited to discussing systematic reviews.

The study points to the continuing issue of insufficient evidence regarding effective interventions to prevent or manage radiodermatitis, as well as design and reporting limitations of many of the studies in this area. Further research is needed in this area.

To investigate the effects of a natural, oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation-induced skin reactions

Patients received either cream 1 (the natural, oil-based emulsion containing allantoin [Moogoo Udder Cream]) or cream 2 (aqueous cream). The allantoin emulsion contained multiple other ingredients, including aloe. Patients were stratified by irradiated site, body mass index, and smoking status, and they randomly were assigned to the intervention. Patients applied the cream to irradiated skin twice daily or more as needed. If moist desquamation occurred, the treatment was discontinued until healing occurred. Study assessments were completed weekly. The creams for both arms had a similar appearance and were manufactured in a plain tube. The participants and researchers remained blinded until the end of the study when codes on the tubes revealed the study arm. Inter-rater reliability was measured and resulted in an intraclass correlation of 1.0 (perfect agreement). A sample size calculation was conducted; 81 participants were required for each arm, and ≥ 81 participants completed each arm.

• N = 173 (randomized)
• MEAN AGE = 60–61 years
• MALES: 64.4%, FEMALES: 35.6%
• KEY DISEASE CHARACTERISTICS: Lung, breast, and head and neck cancers

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: Brisbane, Australia

• PHASE OF CARE: Active antitumor treatment

Double-blinded, blocked, randomly assigned, controlled, phase III clinical trial

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v4) to measure skin toxicity
• Skindex-16 to measure skin-related quality of life
• Brief Pain Inventory (BPI) to measure pain
• Itching was measured using a numeric analog scale (NAS) where 0 = none and 10 = worst imaginable.

Patients who received cream 1 had a significantly lower average CTCAE score at week 3 (p < 0.05) but had statistically higher average levels of skin toxicity at weeks 7, 8, and 9 (all p < 0.001). Similar results were observed when skin toxicity was analyzed by grades. In regard to pain, patients in the cream 2 group had significantly higher average worst-pain scores (p < 0.05) and itching (p = 0.046) compared to the cream 1 group at week 3; however, these differences were not observed during other weeks. In addition, there was a strong trend for cream 2 to reduce the incidence of grade 2 or more skin toxicity in comparison with cream 1 (p = 0.056). Overall, more participants in the cream 1 group were required to use another topical treatment at weeks 8 (p = 0.049) and 9 (p = 0.01).

Overall, this was a well designed study. However, some participants used prescribed creams in addition to the assigned study cream, making it difficult to know the true effects of the study creams. The cream containing allantoin performed better during the first five weeks of treatment but worse thereafter.

• Unintended interventions or applicable interventions not described that would influence results
• Questionable protocol fidelity
• Other limitations/explanation: This study was partially funded by an industry (Moogoo Skin Care in Australia). However, the authors report that the industry was not involved in the study design or the preparation of the manuscript. The participants were told to apply the cream twice per day or as needed. Participants in both arms admitted to using additional creams other than the assigned study cream. For example, 34 of 89 participants (38%) in the cream 1 (the study cream with allantoin) arm reported using an additional cream at week 8. Limitations included the study's inability to measure skin dose. Instructing patients to apply as needed contributes to this limitation.

Additional studies with improved “buy-in” from participant healthcare providers to reduce the use of non-study creams are needed. This study does not provide strong evidence for the effectiveness of this intervention as findings varied at different time points and there were several study limitations. Nurses' awareness of the importance of using the CTCAE for grading skin toxicities related to topical treatments is vital in standardizing assessments. Moogoo Udder Cream is available in the United States (http://moogoousa.com/udder-cream-skin-milk.html), but not in stores.