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Metastatic Breast CancerNCT03045289

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

A study testing Plant-Based Diet in people with Metastatic Breast Cancer and Breast Cancer Stage IV, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Plant-Based Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
5 Jul 2018to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

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

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.

Being tested
Plant-Based Diet
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plant-Based DietBehavioural

    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.

Study groups in NCT03045289
Study groupRoleWhat they receive
Intervention groupExperimentalSubjects are provided three meals daily, attend weekly office visits, take a daily multivitamin.
Receives: Behavioral: Plant-Based Diet
Control GroupNo interventionWomen instructed to maintain current intake and take a provided multivitamin.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

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

    Measured: 1 year

  2. Retention

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

    Measured: 8 weeks

  3. Compliance

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

    Measured: 8 weeks

Secondary outcomes (16)

  1. FACT-B

    Measured: 8 weeks

  2. EORTC QLQ-C30

    Measured: 8 weeks

  3. FACT-COG

    Measured: 8 weeks

  4. Brief Fatigue Inventory (BFI)

    Measured: 8 weeks

  5. Symptom Inventory

    Measured: 8 weeks

  6. Serum breast cancer biomarkers

    CA 15-3, CEA, CA 27.29

    Measured: 8 weeks

  7. Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT)

    Measured: 8 weeks

  8. Changes in nutrient intakes based on 3 day food diaries

    Assess baseline diet compared to intervention diet

    Measured: 8 weeks

  9. Weight

    Measured: 8 weeks

  10. Blood Pressure

    Measured: 8 weeks

  11. Inflammatory Markers

    CBC, CRP

    Measured: 8 weeks

  12. Hormonal Levels

    Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3

    Measured: 8 weeks

  13. Metabolic Markers

    Lipids, CMP

    Measured: 8 weeks

  14. Tumor Metabolic Activity

    PET/CT scan SUV Uptake

    Measured: 8 weeks

  15. Circulating Tumor Cells

    Measured: 8 weeks

  16. cell-free DNA

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2017 (estimated)
  2. Study start5 Jul 2018
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03045289
Sponsor's protocol ID
RSRB00066846
Status last verified
Jul 2022
First submitted
1 Feb 2017
Last updated
13 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be made available for collaboration or other purposes with appropriate data use agreements in place.

Publications

  • Campbell 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.

    PubMed 42473551

  • 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.

    PubMed 39702320

  • 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.

    PubMed 39417128

  • 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.

    PubMed 38553649

  • 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.

    PubMed 38446316

  • 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.

    PubMed 38045318

  • 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.

    PubMed 37986940

Questions about this trial

What is this clinical trial studying?

A study testing Plant-Based Diet in people with Metastatic Breast Cancer and Breast Cancer Stage IV, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045289, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.

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