Randomized trial of decongestive lymphatic therapy for the treatment of lymphedema in women with breast cancer.

PURPOSE: Because of its morbidity and chronicity, arm lymphedema remains a concerning complication of breast cancer treatment. Although massage-based decongestive therapy is often recommended, randomized trials have not consistently demonstrated benefit over more conservative measures. PATIENTS AND METHODS: Women previously treated for breast cancer with lymphedema were enrolled from six institutions. Volumes were calculated from circumference measurements. Patients with a minimum of 10% volume difference between their arms were randomly assigned to either compression garments (control) or daily manual lymphatic drainage and bandaging followed by compression garments (experimental). The primary outcome was percent reduction in excess arm volume from baseline to 6 weeks. RESULTS: A total of 103 women were randomly assigned, and 95 were evaluable. Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group (difference, 6.4%; 95% CI, -6.8% to 20.5%; P = .34). Absolute volume loss was 250 mL and 143 mL in the experimental and control groups, respectively (difference, 107 mL; 95% CI, 13 to 203 mL; P = .03). There was no difference between groups in the proportion of patients losing 50% or greater excess arm volume. Quality of life (Short Form-36 Health Survey) and arm function were not different between groups. CONCLUSION: This trial was unable to demonstrate a significant improvement in lymphedema with decongestive therapy compared with a more conservative approach. The failure to detect a difference may have been a result of the relatively small size of our trial.

Lymphedema in women with breast cancer: characteristics of patients screened for a randomized trial.

INTRODUCTION: Accrual rates for a randomized trial of decongestive therapy in breast cancer patients with lymphedema were lower than anticipated. In two centres, patients presenting to lymphedema clinic were screened for eligibility to understand the accrual process and help define the patient population. MATERIALS AND METHODS: All breast cancer patients presenting to two lymphedema clinics in regional cancer centres were screened for study entry. Circumferential arm measurements were taken and volumes calculated. Patients were then screened for trial eligibility. All report forms were sent to the trial coordinating centre. RESULTS: A total of 408 patients were screened. Median arm volume excess was 239 ml (9.5%). One third of patients had little or no excess volume. Only 28.3% of patients had sufficient excess volume for trial eligibility. Of these, a significant number of patients were excluded because of active malignancy or previous decongestive therapy. CONCLUSIONS: The finding of moderate to severe lymphedema observed in clinics screening for trial eligibility was less than expected. The natural history of lymphedema in breast cancer patients is potentially changing. Some patients may be presenting with sensory changes suggestive of lymphedema but due to other causes, such as nerve disruption following axillary dissection.

Oxybutynin for refractory hot flashes in cancer patients.

OBJECTIVE: There is little information available on the treatment of hot flashes in patients refractory to pharmaceutical interventions. Anecdotal evidence led to the use of oxybutynin for the management of hot flashes in refractory cancer patients; therefore, we performed a retrospective chart review of such patients to determine the effect of oxybutynin in treating hot flashes and to observe the side effects of the drug in these patients. DESIGN: A prospective database of all patients treated for hot flashes was started in July 2004 and was retrospectively analyzed as of March 2006. Also included were individual charts preceding July 2004. Fifty-two patient charts were examined. Demographic information was obtained along with baseline severity and frequency of hot flashes, dose and duration of treatment with oxybutynin, patient response to oxybutynin, and side effects. RESULTS: More than 90% of patients analyzed were refractory to hot flash treatments before starting oxybutynin. Seventy percent of patients showed a partial or excellent response to oxybutynin. The duration of oxybutynin use ranged from 2 weeks to 5 years with more than half of patients currently on oxybutynin or taking oxybutynin for longer than 6 months. Of those patients who experienced an excellent or partial response to treatment, 12% stopped because of documented oxybutynin-related side effects within 4 weeks. CONCLUSION: Oxybutynin seems promising in the management of hot flashes with tolerable side effects in the majority of refractory patients. A placebo-controlled, randomized study is being developed to look more closely at the effectiveness of oxybutynin in reducing hot flashes.

The treatment of lymphedema related to breast cancer: a systematic review and evidence summary.

GOALS OF WORK: To provide an evidence summary report on the question: What are the treatment options for women with lymphedema following treatment for breast cancer? METHODS: Cancer Care Ontario's Supportive Care Guidelines Group (SCGG) employed systematic review methodology to produce an evidence summary on this topic. Evidence-based opinions were formulated to guide clinical decision making, and a formal external review process was conducted to validate the relevance of these opinions for Ontario practitioners. RESULTS: The systematic review search strategy identified ten randomized controlled trials which form the basis of this evidence summary report. Four key opinions offered by the SCGG are outlined below. Responses from the practitioner feedback process supported the validity of these opinions in Ontario. (1) There is some evidence to suggest that compression therapy and manual lymphatic drainage may improve established lymphedema, but further studies are needed. Compression garments should be worn from morning to night and be removed at bedtime. Patients should be advised that lymphedema is a lifelong condition and that compression garments must be worn on a daily basis. Patients can expect stabilization and/or modest improvement of edema with the use of the garment in the prescribed fashion. (2) There is no current evidence to support the use of medical therapies, including diuretics. (3) Additional efforts to define relevant clinical outcomes for the assessment of patients with lymphedema would be valuable. (4) These opinions are appropriate for patients with more than mild lymphedema, where the signs and symptoms are considered significant from the patients' perspective.