Daily manual lymphatic drainage and bandaging followed by compression garments did not result in significant improvement in lymphedema compared to a more conservative approach with compression garments only, according to a study evaluating 95 women previously treated for breast cancer with lymphedema.
The women were enrolled from six Canadian regional cancer centers. Inclusion criteria included “lymphedema defined by an absolute increase in arm volume of at least 10% between the ipsilateral (affected) and untreated arm,” the investigators explained. Patients needed to have completed all primary and adjuvant therapy, but they could receive ongoing hormonal therapy or trastuzumab (Herceptin). Among the exclusion criteria were prior decongestive therapy and use of a compression garment within 1 month of enrollment.
Study Design
The women were randomly assigned to the control group, fitted for elastic compression garments consisting of a sleeve (30–40 mm Hg) and glove to be worn for 12 working hours a day, or the experimental complex decongestive therapy group. Patients in this group initially received daily manual lymphatic drainage. A therapist then wrapped compression bandages from the patient’s hand to the shoulder, with the bandages to be worn for the intervening 23 hours. After 4 weeks, these patients were fitted for compression garments similar to those worn by patients in the control group.
“As per Canadian practice guidelines, all patients received advice concerning skin care, exercise, and the maintenance of a healthy body weight,” the authors noted.
There were more patients in the complex decongestive therapy group (56 analyzed) than the control group (39 analyzed), and the patients randomly assigned to complex decongestive therapy had larger mean excess baseline volumes (750 mL) than the controls (624 mL).
“Adherence to compression garments was almost identical between the two groups,” the researchers reported. Over the course of the study, those in the control group wore sleeves an average of 63 hours per week vs 64 in the complex decongestive therapy group. The mean number of hours for wearing gloves was 55 for controls vs 56 for those in the experimental group.
Key Data
“Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group [difference, 6.4%; 95% confidence interval (CI) = –6.8% to 20.5%; P = .34],” the authors, led by Ian S. Dayes, MSc, MD, of Juravinski Cancer Center, Hamilton, Ontario, wrote in the Journal of Clinical Oncology. “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.” Arm function and quality-of-life assessments did not differ between the two groups.
“A total of 28 moderate or severe adverse events occurred that were possibly, probably, or likely related to treatment [nine events in seven patients in the control group vs 19 events in 17 patients in the complex decongestive therapy group, P = .26].” the researchers reported. “Most events consisted of temporary rash or mild to moderate pain in the affected arm. A single episode each of cellulitis and severe pain occurred in the [complex decongestive therapy] group.”
The failure to detect a significant difference in lymphedema with complex decongestive therapy “may have been a result of the relatively small size of our trial,” the authors stated. They noted that their results “are of similar magnitude to those of a recently published meta-analysis of five smaller randomized trials that showed a small but statistically significant benefit of [complex decongestive therapy] over compression garments. Together, these data suggest there may be a small additional benefit of [complex decongestive therapy] over conservative measures alone.” The investigators also pointed out that there is a “significant treatment cost” with complex decongestive therapy due to daily treatment sessions. ■
