Clinical trial · Interventional
A Whole-food, Plant-Based Nutrition Intervention in Women With Metastatic Breast Cancer
Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer: A Pilot Study of Recruitment, Retention, and Preliminary Changes in Biomarkers and Symptoms.
NCT03045289CI-TRIAL-00059625completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plant-Based Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin.
- interventionNames
- Behavioral: Plant-Based Diet
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Women instructed to maintain current intake and take a provided multivitamin.
Primary outcomes (3)
- measure
- Recruitment
- timeFrame
- 1 year
- description
- Percentage of women who are randomized in the study out of the all women approached.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (7)
- DERIVEDCampbell TM, Campbell EK, Blanchard LM, Wixom N, Spath KM, Peppone LJ. Long-Term Dietary Changes and Mortality among Participants of a Whole Food Plant-Based Pilot Study for Metastatic Breast Cancer. Curr Dev Nutr. 2026 Jun 20;10(7):109405. doi: 10.1016/j.cdnut.2026.109405. eCollection 2026 Jul. PMID 42473551
- DERIVEDScales 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
- DERIVEDScales 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
- DERIVEDCampbell 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
- DERIVEDCampbell 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
- DERIVEDCampbell 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.