Home-based exercise and weight-loss programs failed to reduce the incidence of lymphedema in overweight patients with breast cancer, a randomized trial showed.
After a year of evaluation, the primary endpoint of mean interlimb volume did not differ significantly between a control group of women who received standard lymphedema care from certified therapists and three different groups assigned to at-home interventions, in addition to the standard care, reported Kathryn H. Schmitz, PhD, of Pennsylvania State College of Medicine in Hershey, and co-authors.
Objective clinical evaluation of lymphedema scores showed numerical differences favoring the intervention groups (weight loss, exercise, and combined intervention), but the differences did not achieve statistical significance, according to the study online in JAMA Oncology. Patients’ self-reported change in limb volume also did not differ between the control and intervention groups.
“Contrary to the clinical recommendations commonly provided by leading national organizations for patients with breast cancer-related lymphedema (BCRL), a 12-month weight-loss intervention, alone or in combination with a home-based exercise intervention, did not decrease arm swelling or improve the clinical attributes or symptoms of lymphedema,” the researchers wrote. “While a home-based exercise program … was found to be safe, previous research suggests that a supervised, facility-based resistance exercise program may provide greater lymphedema-specific benefits.”
The findings contradicted previous observational studies suggesting that weight loss may improve lymphedema. Subsequently, a pilot study showed weight loss associated with a significant improvement in lymphedema symptoms versus no change in a control group. However, a second pilot study showed no effect of weight loss on arm swelling.
About 40% of breast cancer survivors have diagnosed lymphedema, including half of patients who undergo axillary lymph node dissection (ALND). A recent shift away from ALND to sentinel node biopsy (SNB) has reduced but not eliminated the risk of BCRL, Schmitz and co-authors noted. Even with SNB, patients treated with radiotherapy have an increased risk of lymphedema. Racial/ethnic disparities in use of SNB have contributed to higher rates of BCRL in black women.
“In short, BCRL has not been eradicated,” the authors stated.”Women with BCRL deserve evidence-based approaches to improve outcomes for this chronic condition.”
Study Details
Guided by results of prior studies, Schmitz and colleagues designed a four-arm randomized trial to evaluate the addition of home-based interventions to standard lymphedema care for women with breast cancer. Given the association between excess weight and lymphedema, the investigators limited enrollment to women with a body mass index (BMI) of 25-50. The team recruited 351 women who remained cancer free 6 months after completing treatment and had a prior or current diagnosis of lymphedema.
Study participants were allocated to a control group who received standard lymphedema care or to one of three experimental groups who engaged in at-home interventions in addition to standard care. One intervention group followed a prescribed weight-loss regimen, one engaged in a prescribed exercise regimen, and participants in the third group followed both at-home interventions. The primary endpoint was the percentage change in interlimb volume differences at 12 months, as measured objectively by perometry. Secondary objectives included results of clinical and self-reported assessments.
The study population consisted of 218 (62.1%) white patients, 122 (34.8%) black patients, and 11 (3.1%) of other racial/ethnic groups. Median time since breast cancer diagnosis was 6 years and ranged from 1 to 29 years. Median BMI was 34. Baseline characteristics were evenly distributed across the four groups. Baseline interlimb difference ranged from 7.6 to 9.6 across the four treatment groups.
After 12 months, pairwise comparisons showed no significant differences between any of the intervention groups versus the control group for change in upper-extremity limb volume:
- Combined group — 0.66% (95% CI -0.88 to 2.20)
- Weight loss — 0.53% (95% CI -1.04 to 2.10)
- Exercise — 0.04% (95% CI -1.57 to 1.65)
Mean changes in extremity volume by self-report were -0.39, -0.12, -0.57, and -0.62 in the control, exercise, weight-loss, and combined groups, respectively. Weight loss from baseline averaged -0.55% of body weight in the control group, and -0.44%, -7.37%, and -8.06% in the exercise, weight-loss, and combined groups. The frequency of lymphedema exacerbations or cellulitis also did not differ by treatment group (P>0.50 for all comparisons).
The study was supported by the National Institutes of Health, with contributions from BSN Medical and Nutrisystem.
Schwartz disclosed relationships with BSN Medical, Klose Training, and a patent interest; multiple co-authors disclosed relationships with the pharmaceutical industry and other commercial and noncommercial entities.
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Source: MedicalNewsToday.com
