Evidence map›Paper›PMID 38446316›Full record

Trial reportBreast cancer research and treatment2024

A whole-food, plant-based randomized controlled trial in metastatic breast cancer: weight, cardiometabolic, and hormonal outcomes.

Thomas M Campbell, Erin K Campbell, Eva Culakova, Lisa M Blanchard, Nellie Wixom, Joseph J Guido, James Fetten, Alissa Huston, Michelle Shayne, Michelle C Janelsins and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03045289 (Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03045289 nacompletednot on this map

Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer: A Pilot Study of Recruitment, Retention, and Preliminary Changes in Biomarkers and Symptoms.

TypeinterventionalSponsorUniversity of RochesterRan2018 to 2022Enrolled32ConditionsMetastatic Breast Cancer, Breast Cancer Stage IVArmsPlant-Based Diet
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Chemopreventive and therapeutic effects ofFrontiers in pharmacology · 2025
    Article
  11. Article
  12. Article
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  14. Review
  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Thomas M CampbellDepartment of Family Medicine, University of Rochester Medical Center, 777 South Clinton Ave, Rochester, NY, 14620, USA. Thomas_campbell@urmc.rochester.edu.ORCID http://orcid.org/0000-0003-4449-8229
Erin K CampbellDepartment of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, USA.
Eva CulakovaDepartment of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, NY, USA.
Lisa M BlanchardDepartment of Family Medicine, University of Rochester Medical Center, 777 South Clinton Ave, Rochester, NY, 14620, USA.
Nellie WixomClinical Research Center, University of Rochester Medical Center, Rochester, NY, USA.
Joseph J GuidoDepartment of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, NY, USA.
James FettenMemorial Sloan Kettering Cancer Center, Westchester, NY, USA.
Alissa HustonDepartment of Medicine, Hematology/Oncology, University of Rochester Medical Center, Rochester, NY, USA.
Michelle ShayneDepartment of Medicine, Hematology/Oncology, University of Rochester Medical Center, Rochester, NY, USA.
Michelle C JanelsinsDepartment of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, NY, USA.
Karen M MustianDepartment of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, NY, USA.
Richard G MooreDepartment of Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, NY, USA.
Luke J PepponeDepartment of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, NY, USA.
University of Rochester Medical Center · USMemorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
NCI NIH HHS P30 CA008748NCI NIH HHS UG1 CA189961US National Institutes of Health UG1-CA189961
6 · The paper itself

Abstract

purposeBreast 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.

methodsWomen 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.

resultsWithin 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.

conclusionWFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight, 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.

Indexed as

Breast NeoplasmsAdultAgedBody WeightCardiometabolic Risk FactorsDiet, VegetarianFemaleHumansInsulinInsulin ResistanceMiddle AgedNeoplasm MetastasisObesitySex Hormone-Binding GlobulinTestosteroneTreatment OutcomeInsulinSex Hormone-Binding GlobulinTestosteroneBreast cancerDietNutritionObesityPlant-based dietVegan diet

Identifiers

PMID38446316
PMCPMC11101531
OpenAlexW4392499449

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.