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Randomized Controlled Trial
. 2023 Dec 1;41(34):5285-5295.
doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1.

Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study

Tara Sanft  1   2 , Maura Harrigan  3 , Courtney McGowan  3 , Brenda Cartmel  2   3 , Michelle Zupa  3 , Fang-Yong Li  3 , Leah M Ferrucci  2   3 , Leah Puklin  3 , Anlan Cao  3 , Thai Hien Nguyen  3 , Marian L Neuhouser  4 , Dawn L Hershman  5 , Karen Basen-Engquist  6 , Beth A Jones  2   3 , Tish Knobf  2   7 , Anees B Chagpar  1   2 , Andrea Silber  1   2 , Anna Tanasijevic  8 , Jennifer A Ligibel  8 , Melinda L Irwin  2   3
Affiliations
Randomized Controlled Trial

Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study

Tara Sanft et al. J Clin Oncol. .

Abstract

Purpose: Successful completion of chemotherapy is critical to improve breast cancer outcomes. Relative dose intensity (RDI), defined as the ratio of chemotherapy delivered to prescribed, is a measure of chemotherapy completion and is associated with cancer mortality. The effect of exercise and eating a healthy diet on RDI is unknown. We conducted a randomized trial of an exercise and nutrition intervention on RDI and pathologic complete response (pCR) in women diagnosed with breast cancer initiating chemotherapy.

Methods: One hundred seventy-three women with stage I-III breast cancer were randomly assigned to usual care (UC; n = 86) or a home-based exercise and nutrition intervention with counseling sessions delivered by oncology-certified registered dietitians (n = 87). Chemotherapy dose adjustments and delays and pCR were abstracted from electronic medical records. T-tests and chi-square tests were used to examine the effect of the intervention versus UC on RDI and pCR.

Results: Participants randomly assigned to intervention had greater improvements in exercise and diet quality compared with UC (P < .05). RDI was 92.9% ± 12.1% and 93.6% ± 11.1% for intervention and UC, respectively (P = .69); the proportion of patients in the intervention versus UC who achieved ≥85% RDI was 81% and 85%, respectively (P = .44). The proportion of patients who had at least one dose reduction and/or delay was 38% intervention and 36% UC (P = .80). Among 72 women who received neoadjuvant chemotherapy, women randomly assigned to intervention were more likely to have a pCR than those randomly assigned to UC (53% v 28%; P = .037).

Conclusion: Although a diet and exercise intervention did not affect RDI, the intervention was associated with a higher pCR in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative and triple-negative breast cancer undergoing neoadjuvant chemotherapy.

Trial registration: ClinicalTrials.gov NCT03314688.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Andrea Silber

Honoraria: AstraZeneca/Daiichi Sankyo

Consulting or Advisory Role: AstraZeneca/Daiichi Sankyo

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
The LEANer study schema. DFCI, Dana-Farber Cancer Institute; EPIC, electronic portfolio of international credentials; LEANer, Lifestyle, Exercise, and Nutrition Early After Diagnosis; MD, medical doctor; pCR, pathologic complete response.
See this image and copyright information in PMC

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