ASTRO: Modest Benefit Seen with Decongestive Therapy
Reported November 05, 2009
CHICAGO — Breast cancer patients with treatment-related lymphedema derived only a modest benefit from decongestive lymphatic therapy compared with a compression sleeve, results of a randomized multicenter Canadian study showed.
The massage-based decongestive therapy reduced fluid volume by less than 7% compared with a compression sleeve, a difference that did not achieve statistical significance.
However, the absolute difference between groups exceeded 100 ml, which gave decongestive therapy a significant advantage over the sleeve (P=0.02).
Women with longstanding lymphedema appeared to benefit most from decongestive therapy, said Ian Dayes, MD, of McMaster University in Hamilton, Ont.
“These results would suggest that there is a modest further reduction in absolute volume in those patients who received massage and bandaging compared with those patients who received elastic sleeve alone,” Dayes said here at the American Society for Radiation Oncology.
“There certainly seems to be more relative benefit in those patients who have longstanding lymphedema as compared with those patients who had lymphedema for less than a year.”
Despite extensive clinical experience with decongestive therapy, the treatment had never been evaluated in a randomized clinical trial.
To address that shortcoming, investigators at six Canadian centers enrolled 103 patients who had lymphedema following completion of breast cancer therapy. Eligible patients had at least a 10% difference in volume between the affected and contralateral arm.
Eight patients withdrew consent, and the remaining 95 had an imbalance in randomization, as 56 patients were assigned to decongestive therapy and 39 to the compression sleeve.
Decongestive therapy consisted of daily one-hour massage by a licensed therapist, continuing for four weeks. The patients wore gauze and bandages for the remaining 23 hours a day. After completing the massage therapy, patients were fitted for an elastic compression sleeve and glove, which they wore for 12 hours a day. They also received advice on skin care, exercise, and diet.
Control therapy consisted of the compression sleeve and glove and advice about skin care, exercise, and diet.
The primary outcome was the change in volume of the treated arm at the end of decongestive therapy, calculated from circumferential measurements.
The contralateral arm was used for comparison. Measurements were obtained at baseline, during and after treatment, and at weeks 12, 24, and 52. Secondary outcomes included absolute change in arm volume in milliliters, quality of life, and arm function as assessed by a standardized instrument.
At baseline, excess arm volume averaged 684 mL (27%) for all 103 patients, 698 mL (27%) for the 95 evaluable patients, 751 mL (29%) in patients assigned to decongestive therapy, and 624 mL (24%) in the control group.
At the study’s completion, reduction in arm volume averaged 29.3% in the experimental group and 22.6% in the control group (P=0.32). The absolute reduction averaged 252 mL with decongestive therapy and 143 mL in the control group, a difference that achieved statistical significance (P=0.02).
A prespecified analysis of the results by duration of lymphedema also revealed a statistically significant absolute difference.
Among patients with lymphedema for less than a year, the absolute reduction in arm volume averaged 150 to 200 mL in both groups. However, women with lymphedema for a year or longer had a mean volume reduction of 320 to 330 mL with decongestive therapy versus a little more than 100 mL with the compression devices alone (P=0.02).
Scores on assessments of quality of life and arm function did not change significantly in either group and did not differ between groups.
Dayes said data from long-term follow-up will be analyzed and reported in the future.
Primary source: American Society for Radiation Oncology