Breast Cancer MetastaticBEND-MBECNCT07189702
Plant-Based Nutrition for Breast or Endometrial Cancer
A study testing Whole Food, Plant-Based Diet with Behavioral Education and Support in people with Breast Cancer Metastatic and Endometrial Cancer Stage IV, run by University of Rochester.
Trial summary
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Metastatic, Endometrial Cancer Stage IV
- What is being tested?
- Whole Food, Plant-Based Diet with Behavioral Education and Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial of Behavioral Education and Nutrition Delivery in Women With Metastatic Breast and Endometrial Cancer. (The BEND-MBEC Study)
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer.
Read the detailed description
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer. It is designed to explore whether this dietary intervention is sustainable in this population for 26 weeks and whether improvements in quality of life and cardiometabolic health demonstrated in a previous study are sustained. If so, this study will gather information to know whether these benefits translate into reduced overall mortality and cancer markers when compared with a control group that is matched for time and attention but does not implement dietary change. The intervention consists of a whole food plant-based dietary program, group education and individual coaching/visits while the control group gets general wellness group education and individual visits while maintaining their usual diet.
- Being tested
- Control, Whole Food, Plant-Based Diet with Behavioral Education and Support
- Keywords
- Metastatic, Metastatic Breast, Metastatic Endometrial, Breast Stage IV, Endometrial Stage IV, Nutrition, Plant-Based Nutrition
- Medical subject headings
- Endometrial Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Regular Diet with Cancer-Related Wellness Education and Support
Whole Food, Plant-Based Diet with Behavioral Education and SupportOther
Whole Food, Plant-Based Diet with Behavioral Education and Support
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Regular Diet with Cancer-Related Wellness Education and Support Receives: Other: Control |
| Whole Food, Plant-Based Diet with Behavioral Education and Support | Experimental | Whole Food, Plant-Based Diet with Behavioral Education and Support Receives: Other: Whole Food, Plant-Based Diet with Behavioral Education and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Dietary Adherence at 13 and 26 Weeks
Dietary adherence is assessed by study personnel using pre-specified criteria. Participants are considered "adherent" if ≥80% of total calories are consumed from 'on-plan' foods. A single adherence score is calculated as the percentage of calories consumed from on-plan foods, averaged over the assessment period. Higher scores indicate greater adherence.
Measured: 13 weeks, 26 weeks
Mean Change in Participant Retention at 13 and 26 Weeks
Retention is calculated as the percentage of consented participants who provide both baseline and post-intervention assessments. Higher percentages indicate better retention in the WFPB dietary intervention.
Measured: 13 weeks, 26 weeks
Secondary outcomes (14)
Mean Change in Disease-Specific Quality of Life - FACT-B at 13 and 26 Weeks
Quality of life is assessed using the Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire. Individual item scores are summed to create subscale scores and a total score, with higher scores indicating better quality of life. Mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Disease-Specific Quality of Life - FACT-En at 13 and 26 Weeks
Quality of life is assessed using the Functional Assessment of Cancer Therapy - Endocrine (FACT-En) questionnaire. Item responses are summed for subscales and a total score, with higher scores indicating better QOL. Mean change from baseline is evaluated.
Measured: 13 weeks, 26 weeks
Mean Change in Cognitive Dysfunction (FACT-COG) at 13 and 26 Weeks
Cognitive function is measured using the FACT-COG questionnaire. Items are summed to generate a total cognitive dysfunction score. Higher scores indicate greater cognitive function (less dysfunction). Mean change from baseline is calculated to assess improvement or decline.
Measured: 13 weeks, 26 weeks
Mean Change in Cancer-Related Fatigue (BFI) at 13 and 26 Weeks
Fatigue is assessed using the Brief Fatigue Inventory (BFI). Scores for each item range from 0 (no fatigue) to 10 (severe fatigue) and are averaged to obtain a total fatigue score. Lower scores indicate less fatigue. Mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in General Symptoms (MDASI) at 13 and 26 Week
General symptoms are measured using the MD Anderson Symptom Inventory (MDASI). Items are rated 0-10, with higher scores indicating greater symptom severity. Total symptom burden is calculated by summing items. Mean change from baseline is evaluated to assess improvement.
Measured: 13 weeks, 26 weeks
Overall Survival at Close of Study
Overall survival is defined as the time from study enrollment to death from any cause. Survival status is determined through medical records and follow-up.
Measured: End of study (26 weeks)
Mean Change in Cardiometabolic Marker (Weight) at 13 and 26 Weeks
Weight is collected at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Lipids) at 13 and 26 Weeks
Lipids are measured at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Blood Pressure) at 13 and 26 Weeks
Blood Pressure is measured at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Insulin) at 13 and 26 Weeks
Insulin is measured at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Inflammation) at 13 and 26 Weeks
Inflammation is measured at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Blood Glucose) at 13 and 26 Weeks Description:
Blood Glucose is measured at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Hormonal Marker (IGF1) at 13 and 26 Weeks
Description: IGF1 is measured at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Mean Change in Hormonal Marker (sex hormones) at 13 and 26 Weeks
Sex hormones are measured at each time point, and mean change from baseline is calculated.
Measured: 13 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas M Campbell, University of Rochester
- Investigators
- Thomas M Campbell, MD, Principal investigator, University of RochesterErin K Campbell, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189702
- Sponsor's protocol ID
- STUDY00010949
- Acronym
- BEND-MBEC
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Behavioral Education and Nutrition Delivery in Women With Metastatic Breast and Endometrial Cancer. (The BEND-MBEC Study)
- ClinicalTrials.gov ID
- NCT07189702
- Acronym / sponsor ID
- BEND-MBEC / STUDY00010949
- Keywords
- Metastatic, Metastatic Breast, Metastatic Endometrial, Breast Stage IV, Endometrial Stage IV, Nutrition, Plant-Based Nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer.
Detailed description
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer. It is designed to explore whether this dietary intervention is sustainable in this population for 26 weeks and whether improvements in quality of life and cardiometabolic health demonstrated in a previous study are sustained. If so, this study will gather information to know whether these benefits translate into reduced overall mortality and cancer markers when compared with a control group that is matched for time and attention but does not implement dietary change. The intervention consists of a whole food plant-based dietary program, group education and individual coaching/visits while the control group gets general wellness group education and individual visits while maintaining their usual diet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlRegular Diet with Cancer-Related Wellness Education and Support |
| Whole Food, Plant-Based Diet with Behavioral Education and Support | Experimental | Other: Whole Food, Plant-Based Diet with Behavioral Education and SupportWhole Food, Plant-Based Diet with Behavioral Education and Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlRegular Diet with Cancer-Related Wellness Education and Support | Other | Control |
| Whole Food, Plant-Based Diet with Behavioral Education and SupportWhole Food, Plant-Based Diet with Behavioral Education and Support | Other | Whole Food, Plant-Based Diet with Behavioral Education and Support |
Primary outcome
Mean Change in Dietary Adherence at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Dietary adherence is assessed by study personnel using pre-specified criteria. Participants are considered "adherent" if ≥80% of total calories are consumed from 'on-plan' foods. A single adherence score is calculated as the percentage of calories consumed from on-plan foods, averaged over the assessment period. Higher scores indicate greater adherence.
Mean Change in Participant Retention at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Retention is calculated as the percentage of consented participants who provide both baseline and post-intervention assessments. Higher percentages indicate better retention in the WFPB dietary intervention.
14 secondary outcomes
Mean Change in Disease-Specific Quality of Life - FACT-B at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Disease-Specific Quality of Life - FACT-En at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Cognitive Dysfunction (FACT-COG) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Cancer-Related Fatigue (BFI) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in General Symptoms (MDASI) at 13 and 26 Week
Time frame: 13 weeks, 26 weeks
Overall Survival at Close of Study
Time frame: End of study (26 weeks)
Mean Change in Cardiometabolic Marker (Weight) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Lipids) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Blood Pressure) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Insulin) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Inflammation) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Cardiometabolic Marker (Blood Glucose) at 13 and 26 Weeks Description:
Time frame: 13 weeks, 26 weeks
Mean Change in Hormonal Marker (IGF1) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Mean Change in Hormonal Marker (sex hormones) at 13 and 26 Weeks
Time frame: 13 weeks, 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas M Campbell, MD principal investigator
University of Rochester
Erin K Campbell, MD, MPH principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food, Plant-Based Diet with Behavioral Education and Support in people with Breast Cancer Metastatic and Endometrial Cancer Stage IV, run by University of Rochester.
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 0 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M Blanchard, BS (585-953-6709, lisa_blanchard@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Dietary Adherence at 13 and 26 Weeks (time frame: 13 weeks, 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.