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Can a Plant-Based diet improve life for women with metastatic cancer?

NCT ID NCT07189702

Symptom relief Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a whole food, plant-based diet combined with behavioral education can improve quality of life and diet adherence in 60 women with metastatic breast or endometrial cancer. Participants are randomly assigned to either the plant-based diet with support or a regular diet with standard wellness education. The main goals are to see if women can stick to the diet and if it helps them feel better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
whole food, plant-based diet with behavioral education and support
What this could lead to
If successful, this could show that a plant-based diet helps women with advanced breast or endometrial cancer feel better and stick to healthier eating habits.
What could go wrong
This is a small, early-stage trial (60 participants) focused on feasibility and quality of life, not survival. The diet may be hard to follow, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Female sex (as assigned at birth), aged 18 years or older * A confirmed diagnosis of endometrial or metastatic breast cancer. All subtypes are eligible * Treating oncologist approval and expected survival of at least six months * Undergoing any systemic treatment including hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have active cancer and have been recommended but declined systemic treatment are also eligible. * Willing to adopt a strict, whole-foods, plant-based diet * Willing and able to comply with the WFPB protocol for the duration of the study including scheduled testing, Zoom meetings, and office visits * Able to speak and read English fluently. * Women with plans for radiation therapy or surgery are also eligible provided that they meet all other eligibility criteria. Exclusion Criteria: • BMI ≤ 20.0 kg/m2 * Inability to tolerate a normal diet * Active malabsorption syndrome at time of consent, as determined by study physicians (i.e. Crohn's disease, bowel surgery) * Any food allergies or intolerances that would interfere with study compliance * Recent consumption (in the past six months) of a vegan diet * eGFR \< 30 on ≥ two lab tests in the past six months * Serum potassium \> 5.4 in the past six months * Current insulin or sulfonylurea use * Current warfarin use (non-vitamin K antagonist allowed) * High-risk alcohol use (\>7 drinks/wk) * Illicit substance use (not including marijuana) * Cognitive impairment or psychiatric disorder impairing ability to give consent.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma endometrial carcinoma endometrium neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer, metastatic Endometrial cancer stage IV

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.