A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes Journal Article


Authors: Campbell, E. K.; Campbell, T. M.; Culakova, E.; Blanchard, L.; Wixom, N.; Guido, J. J.; Fetten, J.; Huston, A.; Shayne, M.; Janelsins, M. C.; Mustian, K. M.; Moore, R. G.; Peppone, L. J.
Article Title: A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes
Abstract: Purpose: Quality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC), and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet-promoting weight loss is feasible and might improve QOL. Methods: Women with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline. Results: 20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3 % total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8 % to 20.4 % percent calories from fat, p < 0.001) and fiber content (12.7 to 30.8 g fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95 % confidence interval [CI] = 0.8–31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5–4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011). Conclusions: Significant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted. Trial Registration: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017. © The Author(s) 2024.
Keywords: adult; clinical article; controlled study; treatment outcome; aged; middle aged; fatigue; metastasis; quality of life; breast cancer; randomized controlled trial; obesity; psychology; pathology; breast neoplasms; confidence interval; questionnaire; insomnia; body mass; disease severity; feasibility study; feasibility studies; breast tumor; neoplasm metastasis; cancer fatigue; cholesterol; patient-reported outcomes; patient reported outcome measures; nutrient; hormone receptor; metastatic breast cancer; ethnicity; carbohydrate; fat; nutrition; patient-reported outcome; feasibility; nutrients; humans; human; female; article; functional well being; acceptability; emotional well-being; vegan diet; whole food; plant-based; plant based; skin problem
Journal Title: Breast Cancer Research and Treatment
Volume: 206
Issue: 2
ISSN: 0167-6806
Publisher: Springer  
Date Published: 2024-07-01
Start Page: 273
End Page: 283
Language: English
DOI: 10.1007/s10549-024-07284-z
PUBMED: 38553649
PROVIDER: scopus
PMCID: PMC11182786
DOI/URL:
Notes: Article -- Source: Scopus
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  1. James Vincent Fetten
    29 Fetten