TY - JOUR
T1 - Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer
T2 - The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial
AU - Sanft, Tara
AU - Harrigan, Maura
AU - Cartmel, Brenda
AU - Ferrucci, Leah M.
AU - Li, Fang Yong
AU - McGowan, Courtney
AU - Zupa, Michelle
AU - Nguyen, Thai Hien
AU - Ligibel, Jennifer
AU - Neuhouser, Marian L.
AU - Hershman, Dawn L.
AU - Basen-Engquist, Karen
AU - Jones, Beth
AU - Knobf, Tish
AU - Chagpar, Anees
AU - Silber, Andrea
AU - Irwin, Melinda L.
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2021/10
Y1 - 2021/10
N2 - Background: The World Cancer Research Fund and the American Cancer Society provide nutrition and physical activity guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines and delay efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse treatment-related side effects and may improve adherence to treatment, resulting in improved breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANer) study is testing the effect of a nutrition and physical activity intervention on chemotherapy completion rates. Methods: 172 women with stage I-III breast cancer undergoing chemotherapy will be randomized 1:1 to a yearlong, 16 session, nutrition and exercise intervention or usual care control group. The intervention is delivered by registered dietitians specializing in oncology nutrition and exercise training. The intervention includes goal setting to meet nutrition and physical activity guidelines for cancer survivors. After each chemotherapy session, date and dose of each drug administered, and reason for dose-adjustments and/or dose-delays are abstracted from the electronic medical record or obtained from the treating oncologist. Chemotherapy completion rate is assessed as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints. Discussion: If successful, this study has the potential to make healthy lifestyle interventions a standard component of breast cancer treatment.
AB - Background: The World Cancer Research Fund and the American Cancer Society provide nutrition and physical activity guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines and delay efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse treatment-related side effects and may improve adherence to treatment, resulting in improved breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANer) study is testing the effect of a nutrition and physical activity intervention on chemotherapy completion rates. Methods: 172 women with stage I-III breast cancer undergoing chemotherapy will be randomized 1:1 to a yearlong, 16 session, nutrition and exercise intervention or usual care control group. The intervention is delivered by registered dietitians specializing in oncology nutrition and exercise training. The intervention includes goal setting to meet nutrition and physical activity guidelines for cancer survivors. After each chemotherapy session, date and dose of each drug administered, and reason for dose-adjustments and/or dose-delays are abstracted from the electronic medical record or obtained from the treating oncologist. Chemotherapy completion rate is assessed as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints. Discussion: If successful, this study has the potential to make healthy lifestyle interventions a standard component of breast cancer treatment.
KW - Breast cancer
KW - Chemotherapy completion
KW - Exercise
KW - Lifestyle
KW - Nutrition
KW - Relative dose intensity
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U2 - 10.1016/j.cct.2021.106508
DO - 10.1016/j.cct.2021.106508
M3 - Article
C2 - 34274495
AN - SCOPUS:85112376661
SN - 1551-7144
VL - 109
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106508
ER -