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[Preprint]. 2023 Nov 8:rs.3.rs-3425125.
doi: 10.21203/rs.3.rs-3425125/v1.

A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome

Thomas M Campbell  1 , Erin K Campbell  1 , Eva Culakova  1 , Lisa Blanchard  1 , Nellie Wixom  1 , Joseph Guido  1 , James Fetten  2 , Alissa Huston  1 , Michelle Shayne  1 , Michelle C Janelsins  1 , Karen M Mustian  1 , Richard G Moore  1 , Luke J Peppone  1
Affiliations

A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome

Thomas M Campbell et al. Res Sq. .

Update in

Abstract

Purpose: Breast cancer treatment is associated with weight gain, and obesity and its related cardiometabolic and hormonal risk factors have been associated with poorer outcomes. Dietary intervention may address these risk factors, but limited research has been done in the setting of metastatic breast cancer requiring systemic therapy.

Methods: Women with metastatic breast cancer on stable treatment were randomized 2:1 to an 8-week intervention (n = 21) or control (n = 11). The intervention included weekly assessment visits and an ad libitum whole food, plant-based (WFPB) diet with provided meals. Cardiometabolic, hormonal, and cancer markers were assessed at baseline, 4 weeks, and 8 weeks.

Results: Within the intervention group, mean weight decreased by 6.6% (p < 0.01) after 8 weeks. Fasting insulin decreased from 16.8 uIU/L to 11.2 uIU/L (p < 0.01), concurrent with significantly reduced insulin resistance. Total cholesterol decreased from 193.6 mg/dL to 159 mg/dL (p < 0.01) and low-density lipoprotein (LDL) cholesterol decreased from 104.6 mg/dL to 82.2 mg/dL (p < 0.01). Total testosterone was unchanged, but free testosterone trended lower within the intervention group (p = 0.08) as sex hormone binding globulin increased from 74.3 nmol/L to 98.2 nmol/L (p < 0.01). There were no significant differences in cancer progression markers at week 8, although mean CA 15 - 3, CA 27.29, and CEA were lower in the intervention group (p = 0.53, p = 0.23, and p = 0.54, respectively) compared to control, when adjusted for baseline.

Conclusion: WFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight and cardiometabolic and hormonal parameters. Longer studies are warranted to assess the durability of changes.

Trial registration: First registered at Clinicaltrials.gov (NCT03045289) on February 7, 2017.

Keywords: Breast cancer; Diet; Nutrition; Obesity; Plant-based diet; Vegan diet.

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Conflict of interest statement

Competing Interests: TMC: Royalties from general interest books about plant-based nutrition (Benbella Books, Penguin Random House) and income from a lifestyle medicine practice, Thomas M. Campbell, MD PLLC; EKC: Conflicts of spouse (TMC); AH: MJH Healthcare Holdings (OncLive), Mediflix (Skipta/Informa); RGM: Consultant for Fujirebio Diagnostics. Research funding from Angle plc. The rest of the authors declare no competing interests.

Figures

Figure 1.
Figure 1.. Potential Mediators Connecting Dietary Intake with Goals of Care
Dietary Intervention may affect breast cancer-related goals of care through several potential mediators, some of which are shown here. This article details how a whole-food, plant-based intervention affects these mediators. Feasibility of the intervention and its affect on quality of life outcomes are published separately (REF).
Figure 2.
Figure 2.. CONSORT diagram
See this image and copyright information in PMC

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