A Whole-food, Plant-Based Nutrition Intervention in Women With Metastatic Breast Cancer

NCT03045289 | Completed DMC

• 1 other identifier: RSRB00066846
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This research will examine the feasibility of conducting a strict whole-food, plant-based dietary intervention in women with stable metastatic breast cancer currently undergoing conventional treatments. In addition, this research will provide preliminary data on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood biomarkers linked to cancer progression, and numerous symptom questionnaires.

Conditions

Metastatic Breast Cancer; Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (3)

• Recruitment

  Percentage of women who are randomized in the study out of the all women approached.

  1 year

• Retention

  Percentage of women who start the intervention who go on to complete 8-week testing

  8 weeks

• Compliance

  The percentage of daily calorie intake from "on-plan" food will be calculated for each participant.

  8 weeks

Secondary Outcomes (16)

• FACT-B

  8 weeks

• EORTC QLQ-C30

  8 weeks

• FACT-COG

  8 weeks

• Brief Fatigue Inventory (BFI)

  8 weeks

• Symptom Inventory

  8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin.

Behavioral: Plant-Based Diet

Control Group

NO INTERVENTION

Women instructed to maintain current intake and take a provided multivitamin.

Interventions

Plant-Based Diet BEHAVIORAL

Women will be provided with 3 meals daily, delivered to their home, for 8 weeks, along with a multivitamin, and will attend weekly office visits.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women will be enrolled due to low numbers of male breast cancer patients and inability to create subgroup analyses.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a confirmed diagnosis of metastatic breast cancer with a stable treatment regimen, demonstrated by no changes in primary cancer therapy 6 weeks prior to consent and no anticipated changes in primary cancer therapy in the 4 weeks following consent.
• Systemic therapy may consist of any conventional treatment including anti-hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have previously declined conventional cancer therapy are also eligible provided they meet all other eligibility criteria.
• Expected to survive for at least 6 months.
• Eligibility classification for enrollment into the study - T: any; N: any; M:1.
• Any ER/PR/HER2 status is eligible.
• Age \> 18 years.
• Must be willing to adopt a strict, whole-foods, plant-based diet.
• Participant must be willing and able to comply with the protocol for the duration of the study including scheduled testing and weekly office visits.
• Able to speak and read English fluently.

You may not qualify if:

• Inability to tolerate a normal diet.
• Current use of insulin or sulfonylureas.
• Active malabsorption syndrome at time of consent (ie. Crohn's disease, major bowel resection leading to permanent malabsorption).
• Current eating disorder.
• Uncontrolled diarrhea.
• Plant-based food allergies or intolerances.
• Recent consumption (in the past 6 months) of a vegan diet.
• GFR \< 30 on 2 or more lab tests in the past 90 days.
• Serum potassium \> 5.3 on 2 or more lab tests in the past 90 days.
• Major surgery within 2 months of starting study program.
• Psychiatric disorder that prohibits giving informed consent.
• Current smoking.
• Current high risk alcohol use (\> 7 drinks per week).
• Current illicit substance use.
• Current warfarin use.

Sponsors & Collaborators

• University of Rochester: lead
• Johns Hopkins University: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (6)

• Scales TQ, Smith B, Blanchard LM, Wixom N, Tuttle ET, Altman BJ, Peppone LJ, Munger J, Campbell TM, Campbell EK, Harris IS. A whole food, plant-based diet reduces amino acid levels in patients with metastatic breast cancer. Cancer Metab. 2024 Dec 19;12(1):38. doi: 10.1186/s40170-024-00368-w.

  PMID: 39702320 DERIVED

• Scales TQ, Smith B, Blanchard LM, Wixom N, Tuttle ET, Altman BJ, Peppone LJ, Munger J, Campbell TM, Campbell EK, Harris IS. A whole food, plant-based diet reduces amino acid levels in patients with metastatic breast cancer. medRxiv [Preprint]. 2024 Oct 22:2024.10.09.24315165. doi: 10.1101/2024.10.09.24315165.

  PMID: 39417128 DERIVED

• Campbell EK, Campbell TM, Culakova E, Blanchard L, Wixom N, Guido JJ, Fetten J, Huston A, Shayne M, Janelsins MC, Mustian KM, Moore RG, Peppone LJ. A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes. Breast Cancer Res Treat. 2024 Jul;206(2):273-283. doi: 10.1007/s10549-024-07284-z. Epub 2024 Mar 30.

  PMID: 38553649 DERIVED

• Campbell TM, Campbell EK, Culakova E, Blanchard LM, Wixom N, Guido JJ, Fetten J, Huston A, Shayne M, Janelsins MC, Mustian KM, Moore RG, Peppone LJ. A whole-food, plant-based randomized controlled trial in metastatic breast cancer: weight, cardiometabolic, and hormonal outcomes. Breast Cancer Res Treat. 2024 Jun;205(2):257-266. doi: 10.1007/s10549-024-07266-1. Epub 2024 Mar 6.

  PMID: 38446316 DERIVED

• Campbell EK, Campbell TM, Culakova E, Blanchard LM, Wixom N, Guido J, Fetten J, Huston A, Shayne M, Janelsins M, Mustian K, Moore RG, Peppone LJ. A Whole Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Feasibility, Nutrient, and Patient-Reported Outcomes. Res Sq [Preprint]. 2023 Nov 21:rs.3.rs-3606685. doi: 10.21203/rs.3.rs-3606685/v1.

  PMID: 38045318 DERIVED

• Campbell TM, Campbell EK, Culakova E, Blanchard L, Wixom N, Guido J, Fetten J, Huston A, Shayne M, Janelsins MC, Mustian KM, Moore RG, Peppone LJ. A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome. Res Sq [Preprint]. 2023 Nov 8:rs.3.rs-3425125. doi: 10.21203/rs.3.rs-3425125/v1.

  PMID: 37986940 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Thomas M Campbell, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Clinical Family Medicine

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 7, 2017
• Study Start: July 5, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)