TY - JOUR
T1 - Effect of Home-Based Exercise and Weight Loss Programs on Breast Cancer-Related Lymphedema Outcomes among Overweight Breast Cancer Survivors
T2 - The WISER Survivor Randomized Clinical Trial
AU - Schmitz, Kathryn H.
AU - Troxel, Andrea B.
AU - Dean, Lorraine T.
AU - Demichele, Angela
AU - Brown, Justin C.
AU - Sturgeon, Kathleen
AU - Zhang, Zi
AU - Evangelisti, Margaret
AU - Spinelli, Bryan
AU - Kallan, Michael J.
AU - Denlinger, Crystal
AU - Cheville, Andrea
AU - Winkels, Renate M.
AU - Chodosh, Lewis
AU - Sarwer, David B.
N1 - Funding Information:
reported receiving grants from the National Cancer Institute and nonfinancial support from BSN Medical during the conduct of the study, personal fees from Klose Training outside the submitted work, and a licensed patent for a Strength After Breast Cancer course. Dr Troxel reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Dean reported receiving grants from the National Cancer Institute, the National Institute of Mental Health, and the National Institute of Allergy and Infectious Diseases during the conduct of the study. Dr DeMichele reported receiving grants from Novartis, Pfizer, Genentech, Calithera, and Menarini outside the submitted work. Dr Brown reported receiving grants from the National Cancer Institute outside the submitted work. Dr Sturgeon reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Denlinger reported receiving grants from the National Cancer Institute during the conduct of the study and grants from BeiGene, AstraZeneca, Sanofi, Amgen, MacroGenics, Agios, Array BioPharma, Lycera, Incyte, Genentech, and Advaxis; grants and personal fees from Bristol-Myers Squibb, Lilly, Bayer, MedImmune, and Merrimack; and personal fees from Merck, EMD Serono, and Carevive outside the submitted work. Dr Cheville reported receiving grants from the National Cancer Institute during the conduct of the study. Dr Chodosh reported receiving personal fees from Imerys Talc America outside the submitted work. Dr Sarwer reported receiving personal fees from BAROnova, Ethicon, Merz, and Novo Nordisk outside the submitted work. No other disclosures were reported.
Funding Information:
Funding/Support: This research was supported by grants US54-CA155850 from the National Institutes of Health (Penn Transdisciplinary Research on Energetics and Cancer Survivor Center), UL1TR001878 from the National Center for Advancing Translational Sciences of the National Institutes of Health, and 5P30CA016520-42 (University of Pennsylvania Abramson Cancer Center) and 5P30CA006927-53 (Fox Chase Cancer Center) from the Comprehensive Cancer Center Support Grants of the National Cancer Institute. Compression garments were donated by BSN Medical, and discounted meal replacements were provided by Nutrisystem, Inc. Dr Sarwer was supported by grant R01-DK108628-01 from the National Institutes of Health and the Commonwealth of Pennsylvania. Dr Dean was supported by grants K01CA184288 from the National Cancer Institute, R25MH083620 from the National Institute of Mental Health, P30AI094189 from the Johns Hopkins University Center for AIDS Research, and P30CA006973 from the Sidney Kimmel Cancer Center.
Publisher Copyright:
© 2019 American Medical Association. All rights reserved.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/11
Y1 - 2019/11
N2 - Importance: To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes. Objective: To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors. Design, Setting, and Participants: This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018. Interventions: A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs. Main Outcomes and Measures: The 12-month change in the percentage of interlimb volume difference. Results: Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group. Conclusions and Relevance: Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes.
AB - Importance: To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes. Objective: To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors. Design, Setting, and Participants: This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018. Interventions: A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs. Main Outcomes and Measures: The 12-month change in the percentage of interlimb volume difference. Results: Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group. Conclusions and Relevance: Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes.
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U2 - 10.1001/jamaoncol.2019.2109
DO - 10.1001/jamaoncol.2019.2109
M3 - Article
C2 - 31415063
AN - SCOPUS:85070983545
VL - 5
SP - 1605
EP - 1613
JO - JAMA oncology
JF - JAMA oncology
SN - 2374-2437
IS - 11
ER -