To test the effect of prophylactic 3M Cavilon no-sting barrier film (no-sting) on the rates of moist desquamation compared with sorbolene cream (10% glycerin).

The chest wall was divided into medial and lateral halves, with one half treated with no-sting and the other with sorbolene. No-sting was applied by the nursing staff. Administration began at the start of radiation therapy until two weeks after completion. When a moist desquamation occured, the skin care changed to hydrocolloid dressing.

• The study sample (N = 61) was comprised of female patients with breast cancer.
• Mean age was 58 years, with a range of 30–88 years.
• Thirty-seven patients received chemotherapy, 13 concurrently and 24 sequentially.
• Radiation therapy used a 6 MV photon beam at a dosage of 50 Gy applied tangentially in 25 fractions.

The study took place across multiple sites in Sydney, Australia.

The study used a quasi-experimental design with patients as their own control.

• Patients were assessed from week 1–12.
• The Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer skin scoring assessment was done weekly.
• A five-point Likert scale was used to measure pain and pruritus for each area of the skin.

• Skin dosimetry data in the nonbolus area confirmed that no difference was present in the buildup effect (or lack thereof) between sorbolene and no-sting in those areas outside the skin covered with the bolus material.
• For skin reaction score (p = 0.005) and pruritus (p = 0.011) the no-sting scores were less.
• No evidence was found of a statistically significant trend in the relationship to pain scores or analgesia requirements.
• Nine patients required analgesics for skin reaction in the sorbolene group and eight patients in the no-sting.
• The cost and nursing time was relatively the same per patient, but the peak skin reactions occurred several weeks after radiation therapy was completed.
• Two patients in the no-sting group had treatment delays because of pruritus.

No-sting may be beneficial in the mitigation of skin toxicity with radiation therapy.

• The study did not provide a control group without alternative treatment for comparison.
• In longitudinal follow-up at six weeks data analysis, they included cases for which it was stated that no data was available. It was not clear how these were handled.
• Initial cost of the product showed that no-sting was more expensive.
• There was no subgroup analysis based on concurrent chemotherapy.
• The sample size was small given the variability in patient treatment regimens.

A previous unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine (sorbolene) cream. The different appearances of these products precluded a blinded comparison. To test the ATP principle in a double-blind manner required use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC). This study tested the hypothesis that an ATP alcohol-free barrier film reduces the degree of radiation skin reaction compared with the 10% glycerine cream most commonly used for this purpose in women receiving postmastectomy radiation therapy in Australia.

The chest wall was divided into medial and lateral compartments, and patients were randomized to receive MDBC applied daily to the medial or lateral side and sorbolene to the other side. Patients were instructed to apply the separate creams daily at the start of radiation to each half of the area on the chest wall receiving radiation therapy and to continue until two weeks after radiation completion. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected until week 12, or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters (TLDs).

• N = 318
• AGE = 26–89 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients receiving radiation of at least 45 Gy in 25 fractions after total mastectomy
• OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older, Eastern Cooperative Oncology Group performance status 0–2, ability to consent, ability to attend weekly for up to six weeks after treatment completion. Ineligibility: previous radiation therapy to chest wall, clinically evident cutaneous involvement by malignancy, pregnancy, known allergy to skin  care products

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: 12 radiation treatment centers in Australia

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

• Paired, double-blind, randomized comparison

• TLD measurements were performed twice during radiation with two TLDs per skin compartment. TLDs were centrally calibrated.
• Patient outcomes were scored weekly using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scores.
• Photographic audit of skin scores confirmed the pattern of reactions scored by clinicians.

The MDBC did not reduce peak skin reaction compared to sorbolene. It is possible that this is related to the difference in formulation of the cream compared with film formulation.

• There was no clear consistency on how the cream should be used. Even though it was recommended for daily use, some patients did use it twice a day.

This study emphasizes the requirement for well-designed, appropriately powered, and controlled studies for skin care products. This study also potentially emphasizes that skin care products can vary in effectiveness based on formulation.

Researchers conducted a survey to elicit information that would aid in the evaluation of the potential connection between flying and lymphedema. The study reported on 287 women with relapse-free breast cancer with known pathology/treatment and prospectively measured arm circumferences. Patient and treatment factors were age, type of surgery, number of nodes sampled and number positive, and radiotherapy technique.

Subjects were surveyed by phone and mail regarding flight history, precautions taken, and incidences of arm swelling subsequent to flying.

To compare the effects of compression bandaging and physical exercises versus the same management augmented by an additional 30 minutes of manual lymph drainage

Sixty women post mastectomy were randomly assigned to either a compression bandage group or a manual lymph drainage group. Fifty-one women then completed two weeks of intensive therapy and six months of maintenance therapy (26 weeks total).

• N = 51   
• MEAN AGE = CB-G group: 62 years (SD = 12.2), CDT-G group: 61.2 years (SD = 9.2)
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Breast cancer–related lymphedema

• SITE: Single   
• SETTING TYPE: Outpatient    
• LOCATION: Krakow, Poland

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

• Randomized, noninferiority, prospective study

Summed truncated cone method was used to measures limb segment volume. Limb relative volume change (RVC) was measured using the formula treatment (SLafter treatmentNLbefore)/(NLafter SLbefore), where SL is swollen limb volume and NL is normal limb volume. Edema-related quality of life was measured using the Lymphedema Questionnaire.

In both groups, a significant reduction in SL volume, LE volume, and RVC occurred after each day of the first week of therapy. Within the two-week intensive phase, a significant decrease in SL and LE volumes occured (p < 0.001). A rebound effect occurred in the CB-G group within the first month, but after six months, the SL and LE volumes in both groups were not statistically significant. Six months after finishing intensive therapy, no significant difference in lymph volumes existed between the two groups (p = 0.3).

Patients with postmastectomy LE may have a similar benefit of CDT without MLD on limb edema reduction. Compression bandaging combined with physical exercise may be considered a basic treatment option in limb LE. 

• Small sample (< 100)
• Selective outcomes reporting
• Measurement validity/reliability questionable
• Findings not generalizable
• Subject withdrawals ≥ 10%

The results of this study may help guide overall treatment in women post mastectomy with breast cancer–related lymphedema. However, the effect of manual lymph drainage remains unexplored because immediate lymph fluid draining images and long-term lymphatic changes were not investigated.

To evaluate the efficacy of low-level laser therapy (LLLT) to decrease severe oral mucositis and reduce radiation therapy (RT) interruptions

 Patients received either gallium aluminum arsenide LLLT 2.5 J/cm² or placebo laser before each radiation fraction.

• The study reported on 75 patients with a median age of 55 years.
• The sample was 76% male and 24% female. 
• Patients had head and neck cancer, which was primarily squamous cell carcinoma.
• All patients underwent conventionally fractionated RT s-GY daily fractions, five times per week.

This was a single-site, outpatient study conducted in Brazil.

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blind, phase III study.

• The National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2, was used.
• A visual analog scale was used.

• Appearance of grade 3 mucositis was delayed in the patients treated with LLLT.
• Unplanned RT interruptions because of severe mucositis were necessary for six patients in the placebo arm and none in the LLLT arm.
• Pain scores and analgesic medication use were similar in the two arms.
• No significant differences were found between groups.

LLLT benefit was limited to fewer interruptions in RT.

• The sample size was small with fewer than 100 patients.
• Another dosage or a specific type of LLLT may be more effective.

LLLT dosage, schedule, specific laser type, and availability all need to be addressed.

STUDY PURPOSE: To determine if nystatin prophylaxis or treatment for fungal infection decreases morbidity and mortality in immunocompromised patients

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 14
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,569
• KEY SAMPLE CHARACTERISTICS: Twelve of the 14 trials studied nystatin prophylaxis, and two studied nystatin treatment. Eleven trials included patients with acute leukemia, solid cancer, or bone marrow transplantation. One trial involved patients with liver transplantation, one trial involved patients who were critically ill from surgery and/or trauma, and one trial involved patients with AIDS.

PHASE OF CARE: Active antitumor treatment

Nystatin cannot be recommended for prophylaxis or the treatment of Candida infections in immunodepressed patients.

Nystatin is no more effective than placebo for the prevention or treatment of fungal infections in immunocompromised patients.

To evaluate the efficacy and acceptance of acupuncture as an additive antiemetic treatment during highly emetogenic chemotherapy (HEC) in pediatric patients with cancer

Patients receiving chemotherapy were randomized to receive antiemetic medication plus acupuncture or antiemetic medication alone.

• Group 1 participants received acupuncture before chemotherapy, were offered acupuncture daily during chemotherapy, and received no acupuncture in their subsequent chemotherapy.
• Group 2 received treatments in the opposite order.

Acupuncture points were based on the acupuncturists’ decision, until the patient reported a “de Qi” sensation.

Antiemetic rescue medication, number of retching and vomiting episodes, and a short essay of the acupuncture experience were recorded.

• The sample consisted of 23 participants.
• The patients' ages ranged from 6-18 years with a mean of 13.6 years and standard deviation of 2.9 years.
• The sample was 56.5% female and 43.5% male.
• Diagnoses were Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, undifferentiated sarcoma, and synovial sarcoma.
• Patients who had full control of chemotherapy-induced nausea and vomiting (CINV) without need for antiemetic rescue medication during the first chemotherapy course were excluded from the study.

This study was conducted in multiple inpatient settings in five German cancer centers.

This was a prospective, randomized, crossover clinical trial pilot study.

An open-form essay was used to document the subjective experience of acupuncture.

In evaluating chemotherapy courses, overall, no significant differences were found in retching or vomiting episodes. In evaluating differences between group 1 and group 2, no significant effect was found with dexamethasone (p = 0.145); however, the acupuncture group was associated with lower phenothiazine medication use (p = 0.001) and less retching and vomiting episodes (p = 0.01).

Acupuncture with baseline antiemetic medication was associated with less phenothiazine use and less retching and vomiting among children receiving HEC.

• The sample was small.
• The number of times that the children received acupuncture depended on individual patient requests and was not recorded.
• Acupuncture sessions did not follow a standard procedure of needle placement, and differences among acupuncturists may provide differing results.
• The methods for recording retching and vomiting episodes were not documented.
• Although one of the study aims was to evaluate acceptance of acupuncture, the authors did not specify how this was measured.
• The title suggests that the study evaluated nausea, but this was not discussed.

Acupuncture may provide some relief of retching or vomiting episodes associated with HEC, but the intervention should be used in combination with standard antiemetic treatment.

To assess the effectiveness of hyperbaric oxygen (HBO) therapy on reducing arm lymphedema in patients with early-stage breast cancer

Participants were divided into the control and the experimental group at a ratio of 1 to 2, respectively. The experimental group received HBO therapy and breathed 100% oxygen at 2.4 atmospheres absolute for 100 minutes with two five-minute air breaks. The sessions were conducted 30 times in a six-week period or five times a week. Both the control and experimental groups received patient education on standard care for lymphedema and hosiery when appropriate.

• The study sample was comprised of 58 patients.
• Mean age of the control group was 62.1 years and the experimental group was 63.2 years.
• All patients had breast cancer and most (97%) had diagnosed lymphedema.
• Two patients had Hodgkin lymphoma with radiotherapy.
• Patients had finished adjuvant radiotherapy.
• Patients had a minimum of 15% increase in limb volume.

The study took place in multiple hospitals in the United Kingdom.

Patients were undergoing active lymphedema treatment.

The study used a randomized phase II study design.

• A Perometer measured limb volume.
• An 8% reduction was maintained as a clinically significant reduction in arm volume.
• Lymphoscintigraphy was performed to measure the fractional removal rate of the radioisotopic tracer at baseline and 12 months.
• Acquisitions were performed at 20, 60, 90, 120, and 180 minutes.
• The removal rate was calculated by the computer using a regression slope.
• Extracellular water content was measured at baseline and 12 months using dielectric constant measurements.
• Two measurements were taken: one third the distance from the antecubital crease to the forearm and one half the distance from the antecubital crease to the upper arm.
• Quality of life was assessed using the United Kingdom SF-36, completed before randomization into groups, at baseline, and at 3, 6, 9, and 12 months.

There was not a statistically significant change in limb volume between the control group (p = 0.64) and the experimental group (p = 0.50) at 12 months after baseline. The investigators define a positive response as an 8% reduction in arm volume. Thirty percent of the experimental group versus 18.8% of the control group responded to meet these criteria but was also statistically insignificant (p = 0.50). Lymphatic clearance rates were similar among groups and were not significant findings. Quality of life findings were similar among both groups and were not significant.
 

The study suggests that HBO therapy when added to best standard treatment of lymphedema in patients with breast cancer is not effective. The study does not confirm earlier reports of a therapeutic effect of HBO.

• The sample size was small, with less than 100 participants.
• The sample size for the control and experimental group were different, which could have affected the statistical analysis comparison and leaves room for imbalances.
• The study had a risk of bias because it had no blinding and the sample characteristics.
• The findings are not generalizable.
• The average time from radiotherapy treatment post-operatively to participation in the study was 12 years, which may also effect the results of remodeling of fibrotic tissues from HBO.

The study suggests that HBO therapy is an ineffective therapy for treating lymphedema in patients with breast cancer. The therapy should not be enacted into practice. Nursing researchers should analyze the randomized trial and non-randomized trials of this treatment program to identify confounding variables that may have made the non-randomized trial results significant and the randomized trial results not significant. If the study is repeated a larger sample size should be used.

To examine hyperbaric oxygen in the treatment of chronic arm lymphedema after radiotherapy

Patients received treatment with hyperbaric oxygen, compressed to 2.4 atmospheres absolute (ATA) in a multiplace category 1 hyperbaric chamber at Royal Hospital. Patients received 100% oxygen at pressure via a transparent hood. Total time at 2.4 ATA was 100 minutes, including two five-minute air breaks. Each participant received a total of 30 pressure exposures, treating five days per week for six weeks. The primary endpoint was an absolute change of greater than 20% in relative volume of the ipsilateral arm versus contralateral arm. The secondary endpoints were lymphoscintigraphy, patient self-assessments, and physician assessments. An unplanned endpoint was patient comments about arm softening and mobility as part of one relative change in arm volume. 

• The study sample was comprised of 20 female patients and 1 male patient.
• Patients were included if they had greater than or equal to 30% increase in arm volume, were free from cancer recurrence, physical and psychologic fitness for hyperbaric oxygen, and availability for follow-up and informed consent.
• All patients had axillary or supraclavicular radiotherapy.

The study took place at Royal Marsden Hospital based on observation from a previous study at the same institution evaluating hyperbaric oxygen in radiation-induced brachial plexopathy. In that study, two of the six patients with chronic lymphedema experienced major and persistent improvement in lymphedema.

• Magnetic resonance imaging of the supraclavicular fossa, axilla, and brachial plexus was done prior to treatment to exclude recurrence.
• Subcutaneous induration within the radiotherapy volume was clinically assessed.
• Arm volume was measured using a Perometer.
• Quantitative lymphoscintigraphy was used.
• Clinical photographs were taken.
• Patient completed self-assessments using EORTC QOL (QLQ-C30 and BR23)
• Clinical assessment and Perometer measurements were taken within one week of completing 6 weeks of treatment and at 6 and 12 months after start of therapy.
• Self-assessments occurred at the same intervals as clinical assessments plus three and nine months after start of treatment.
• Lymphoscintigraphy and clinical photos repeated at 12 months only.

Compliance with treatment was 100%. All questionnaires were returned, and only two patients missed follow-up assessments (one patient was hospitalized and the other moved); as a result, 94% of patients had Perometer measures. Only 71% participated in lymphoscintigraphy because of logistics, 7% missed follow-up scan at 12 months, and one scan was erased accidentally. Three patients responded according to defined 20% or greater reduction in arm volume, 16 were nonresponders. Mean percentage reduction in arm volume was 7.68. Quality-of-life measures were not clinically significant post-treatment. Comments by participants indicated they may not have been appropriate measures. Lymphoscinitgraphy improvement showed statistically significant changes.

Patients had good compliance with the treatment plan despite rigorous treatment. Median time since completion of the treatment is 14 years, which is encouraging given improvement in lymphoscintigraphy measures and limb tissue softening (a subjective measure).

• The sample size was small.
• The study did not have a control group or comparison group.

The study has sufficient data to justify a randomized controlled trial. Careful screening of participants is needed.

To evaluate the effects a brief telephone intervention on women experiencing a recurrence of breast cancer

Women were randomly assigned to either a telephone-intervention group (TG) or a control group (CG). TG received 4–8 counseling/information sessions by telephone at weekly intervals. Session content reflected primary patient concerns and common domains from a quality-of-life (QOL) model. After the first session, patients received an information packet. The packet consisted primarily of National Cancer Institute pamphlets. Counselors were breast cancer recurrence survivors at least one year postrecurrence. Assessments were completed at baseline, three months, and six months.

The study was conducted by SWOG (formerly the Southwest Oncology Group)—an organization, supported by the National Cancer Institute, that conducts clinical trials relating to cancer in adults.

• The sample was composed of 305 women experiencing the first recurrence of breast cancer.
• Characteristics of participants in both groups were well balanced except that, in the TG group, more patients received chemotherapy; in the CG group, more patients received hormone therapy.

Multisite

• Cancer Rehabilitation Evaluation System-Short Form (CARES-SF), to measure emotional well-being
• Center for Epidemiological Studies Depression Scale (CESD), to measure depression

Secondary-outcome assessments:

• Four-item scale as proposed by Reynolds et al., to measure social support
• Life Orientation Test (LOT), to measure optimism and pessimism
• Three-point question, to measure surprise regarding recurrence
• Sense of Coherence Scale (Antonovsky), to measure sense of coherence.

Support services utilized and satisfaction with the telephone intervention were requested.

The telephone intervention was feasible and well accepted, but authors noted no benefits associated with the intervention, in regard to either emotional well-being or depressive symptoms. Patient distress started and remained very high in this sample. Statistically significant was the fact that more CG patients progressed during the six months of the study than did members of the TG group.

This is a well-designed RCT with adequate sample size; however, the study’s generalizability is unclear, given that the patients came from multiple institutions across the United States. The catchment cannot be precisely described, and characteristics of refusing patients were not reported. This sample included high levels of psychological and disease-related disability, and telephone calls from a nonprofessional may not have been an appropriate means of modifying patient distress. The study presents no significant findings.