Evidence map›Paper›PMID 38045318›Full record

ArticleResearch square2023

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 M Blanchard, Nellie Wixom, Joseph Guido, James Fetten, Alissa Huston, Michelle Shayne, Michelle Janelsins and 3 more

Registry-linked trialOpen access · greenAbstract readPreprint
In one paragraph

Article in Research square, 2023. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed, 4 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Erin K CampbellUniversity of Rochester Medical Center.ORCID https://orcid.org/0000-0002-6314-1164
Thomas M CampbellUniversity of Rochester Medical Center.
Eva CulakovaUniversity of Rochester Medical Center.
Lisa M BlanchardUniversity of Rochester Medical Center.
Nellie WixomUniversity of Rochester Medical Center.
Joseph GuidoUniversity of Rochester Medical Center.
James FettenMemorial Sloan Kettering Cancer Center.
Alissa HustonUniversity of Rochester Medical Center.
Michelle ShayneUniversity of Rochester Medical Center.
Michelle JanelsinsUniversity of Rochester Medical Center.
Karen MustianUniversity of Rochester Medical Center.
Richard G MooreUniversity of Rochester Medical Center.
Luke J PepponeUniversity of Rochester Medical Center.
University of Rochester Medical Center · USMemorial Sloan Kettering Cancer Center · US

Funding

URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
NCI NIH HHS UG1 CA189961
6 · The paper itself

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 (35.8-20.4% percent calories from fat, p < 0.001) and fiber content (22.1 to 40.8 grams 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.

Indexed as

breast cancermetastatic breast cancernutritionobesitypatient-reported outcomesplant-basedquality of lifevegan diet

Identifiers

PMID38045318
PMCPMC10690314
OpenAlexW4388866594

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.