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Effectiveness of lymphedema prevention programs with compression garment after lymphatic node dissection in breast cancer: a randomized controlled clinical trial [with consumer summary]
Nadal Castells MJ, Ramirez Mirabal E, Cuartero Archs J, Perrot Gonzalez JC, Beranuy Rodriguez M, Pintor Ojeda A, Bascunana Ambros H
Frontiers in Rehabilitation Sciences 2021 Nov 26;2(727256):Epub
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Patients with breast cancer who undergo axillary lymph node dissection (ALND) are at risk of developing lymphedema, which can negatively impact quality of life. Lymphedema prevention programs, which primarily consist of educational content and exercise, have been shown to reduce the incidence of lymphedema. The addition of compression garments (CG) may increase the effectiveness of these programs. AIM: We aimed to determine whether adding a compression garment to a conventional lymphedema prevention program could improve treatment effectiveness. DESIGN: Randomized clinical trial. METHODS: Seventy patients who had undergone ALND for breast cancer were randomized to receive conventional preventative therapy (control arm, n = 35) consisting of a 1-hour educational session and a 12-week exercise program or the same therapy plus upper limb CGs (experimental arm, n = 35). Patients in the experimental arm were instructed to wear the CG >= 8 h/day for the first 3 months after surgery and 2 h/day thereafter. RESULTS: At 2-years, the overall incidence of lymphedema in the two groups was 12.3%, with no significant differences between the conventional and experimental arms (12.5 versus 12.1%). In the experimental arm, the incidence of lymphedema was significantly lower (p = 0.02) in patients who used the CGs daily as recommended compared to patient who did not adhere to this treatment recommendation. Neither exercise (p = 0.518) nor education alone decreased the incidence of lymphedema. Adherence decreased over time. CONCLUSIONS: The findings of this RCT show that health education, preventive exercise programs, and patient adherence to therapeutic recommendations all play an important role in preventing lymphedema.

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