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Clinical Trial
. 2021 Jan 15;127(2):291-299.
doi: 10.1002/cncr.33183. Epub 2020 Oct 20.

A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance)

Electra D Paskett  1 , Jennifer Le-Rademacher  2 , Jill M Oliveri  3 , Heshan Liu  2 , Drew K Seisler  2 , Jeffrey A Sloan  2 , Jane M Armer  4 , Michelle J Naughton  1 , Karen Hock  5 , Michael Schwartz  6 , Gary Unzeitig  7 , Marianne Melnik  8 , Lisa D Yee  9 , Gini F Fleming  10 , John R Taylor  11 , Charles Loprinzi  12
Affiliations
Clinical Trial

A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance)

Electra D Paskett et al. Cancer. .

Abstract

Background: Lymphedema affects many women who are treated for breast cancer. We examined the effectiveness of an education-only (EO) versus education plus sleeve compression/exercise intervention (lymphedema education and prevention [LEAP]) on lymphedema incidence and range of motion (ROM) in a group-randomized trial across 38 cooperative group sites.

Methods: The treating institution was randomly assigned to either EO or LEAP by a study statistician. All patients at a treating institution participated in the same intervention (EO or LEAP) to minimize contamination bias. Participants completed surveys, arm volume measurements, and self-reported ROM assessments before surgery and at 12 and 18 months after surgery. Lymphedema was defined as a ≥10% difference in limb volume at any time post-surgery up to 18 months after surgery or diagnosis by a health provider. Cochran-Mantel-Haenszel tests were used to compare lymphedema-free rates between groups, stratified by lymph node surgery type. Self-reported ROM differences were compared between groups.

Results: A total of 554 participants (56% LEAP) were included in the analyses. At 18 months, lymphedema-free rates were 58% (EO) versus 55% (LEAP) (P = .37). ROM for both arms was greater in LEAP versus EO at 12 months; by 18 months, most women reported full ROM, regardless of group. In LEAP, only one-third wore a sleeve ≥75% of the time; 50% performed lymphedema exercises at least weekly.

Conclusion: Lymphedema incidence did not differ by intervention group at 18 months. Poor adherence in the LEAP group may have contributed. However, physical therapy may speed recovery of ROM. Further research is needed to effectively reduce the incidence and severity of lymphedema in patients who have breast cancer.

Trial registration: ClinicalTrials.gov NCT00376597.

Keywords: breast cancer; education; exercise; lymphedema; prevention; range of motion.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT:

Dr. Loprinzi reports grants from NCI during the conduct of the study. Dr. Paskett reports grants from Merck Foundation and Pfizer during the conduct of the study.

Figures

Figure 1:
Figure 1:
CONSORT diagram for CALGB 70305 (Alliance)
See this image and copyright information in PMC

References

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