There was no difference in the incidence of lymphedema at 18 months in breast cancer patients randomized to a physical therapy intervention with education materials compared with a control.1 Although poor adherence to the intervention may have been a factor, these results, described as “very disappointing” by investigators, suggest that exercise may be unable to prevent this common and troubling side effect of treatment, which afflicts up to half of patients with breast cancer.
More in-depth analyses of quality of life and symptom data by intervention arm and lymphedema status are currently underway. Further research is needed to effectively prevent lymphedema in patients after breast cancer surgery.— Electra D. Paskett, PhD
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“Kaplan-Meier estimate curves of the lymphedema-free rate showed no statistically significant difference in the two groups,” said lead author of the study, Electra D. Paskett, PhD, Professor of Cancer Research at The Ohio State University College of Medicine. “Adherence may explain some of our results: only 31% of women wore the [elastic compression] sleeve at least 75% of the time, and less than half performed breathing and lymph flow exercises at least once a week.”
As Dr. Paskett reported at the 2017 Cancer Survivorship Symposium, lymphedema is a chronic side effect of several cancer surgeries but is most prevalent in breast cancer. Distinguished by swelling and/or pain in an arm or leg, it affects anywhere from 8% to 56% of women and can have a negative financial impact, too. The fiscal burden of lymphedema on patients is estimated to be between $14,877 and $23,167 or more over 2 years.2
“No prevention strategies have been proven effective,” said Dr. Paskett. She noted that although sentinel lymph node dissection has reduced the rate of occurrence, it’s not an ideal mode of prophylaxis.
Study Details
Dr. Paskett and colleagues enrolled women with newly diagnosed, stage I to III breast cancer who were undergoing either axillary lymph node dissection or sentinel node dissection. The researchers collected arm circumference and range-of-motion measurements prior to surgery.
Lymphedema Prevention Study
- A group-randomized trial comparing the effectiveness of two interventions in breast cancer patients—education only vs education and exercise—showed no difference in lymphedema incidence at 18 months.
- Patients who received physical therapy with education materials experienced no difference in lymphedema incidence at 18 months compared with a control.
- Poor adherence in the exercise and education arm may have played a role.
Following surgery, participants were group randomized by clinic to avoid potential contamination between trial arms. Women randomized into the education-only arm were given information about the cause of lymphedema, its signs and symptoms, and risk-reduction strategies published by the American Cancer Society. The other group received the same educational information plus exercise and met one on one with a physical therapist at their institution.
“The physical therapist assessed the patient’s strength range of motion and strength and provided personalized exercises to address any problems,” said Dr. Paskett. “The women also received a DVD that depicted breathing and stretching exercises. Finally, participants were given an elastic compression garment and told when to wear it.”
Overall, 35 cooperative group sites across the country participated in the study. Of the 568 patients enrolled, 45% were in a clinic randomized to the education-only intervention, and 55% were assigned to receive education plus exercise.
No Statistically Significant Difference
After comparing the two trial arms using a log-rank test and associated confidence intervals, researchers found no statistically significant difference in lymphedema-free rates at 18 months. Participants randomized to the education-only intervention had a lymphedema-free rate of 84%, whereas those assigned to the personalized physical therapy intervention with education materials had a lymphedema-free rate of 81%.
Multivariate analysis, however, did distinguish certain risk factors. Women who had undergone mastectomy had an increased risk of developing lymphedema (overall response = 2.58, P = .02). Having one to three positive lymph nodes (overall response = 3.12, P = .01), use of chemotherapy (overall response = 2.93, P = .002), and immediate reconstructive surgery (overall response = 0.19, P = .002) were also predictive of developing lymphedema.
Finally, poor adherence may have negatively influenced results, said Dr. Paskett. Only 31% of women wore the sleeve 75% of the time, and less than half of participants in the physical therapy intervention participated in the “breathing and lymph flow” and “strengthening” exercises. The primary barrier to exercising was being “too busy,” she noted.
“More in-depth analyses of quality of life and symptom data by intervention arm and lymphedema status are currently underway,” Dr. Paskett concluded. “Further research is needed to effectively prevent lymphedema in patients after breast cancer surgery.” ■
Disclosure: Dr. Paskett has stock and ownership interests in Meridian Bioscience and Pfizer and has received research funding from Merck Sharp & Dohme.
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