Evidence map›Paper›PMID 38553649›Full record

Trial reportBreast cancer research and treatment2024

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

Erin K Campbell, Thomas M Campbell, Eva Culakova, Lisa 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 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
6.7field-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

13 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Methodology of analysis of cognitive impairment in longitudinal randomized clinical trials in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Erin K CampbellDepartment of Public Health Sciences, University of Rochester Medical Center, 265 Crittenden Blvd, Rochester, NY, 14642, USA. erin_campbell@urmc.rochester.edu.ORCID http://orcid.org/0000-0002-6314-1164
Thomas M CampbellDepartment of Family Medicine, University of Rochester Medical Center, Rochester, NY, USA.
Eva CulakovaDepartment of Surgery, Cancer Control, University of Rochester Medical Center, Rochester, NY, USA.
Lisa BlanchardDepartment of Family Medicine, University of Rochester Medical Center, Rochester, NY, 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 CA189961NIH HHS UG1-CA189961
6 · The paper itself

Abstract

purposeQuality 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.

methodsWomen 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.

results20 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).

conclusionsSignificant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted.

trial registrationClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

Indexed as

Breast NeoplasmsPatient Reported Outcome MeasuresQuality of LifeAdultAgedFeasibility StudiesFemaleHumansMiddle AgedNeoplasm MetastasisNutrientsTreatment OutcomeNutrientsBreast cancerMetastatic breast cancerNutritionObesityPatient-reported outcomesPlant-basedQuality of lifeVegan diet

Identifiers

PMID38553649
PMCPMC11182786
OpenAlexW4393343793

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.