Plant-Based Nutrition for Breast or Endometrial Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Rochester
About this trial
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Control
Other interventionRegular Diet with Cancer-Related Wellness Education and Support
Whole Food, Plant-Based Diet with Behavioral Education and Support
Other interventionWhole Food, Plant-Based Diet with Behavioral Education and Support
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: Whole Food, Plant-Based Diet with Behavioral Education and SupportExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
13 weeks, 26 weeks2
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.
Time frame
13 weeks, 26 weeksSecondary outcomes
1
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.
Time frame
13 weeks, 26 weeks2
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.
Time frame
13 weeks, 26 weeks3
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.
Time frame
13 weeks, 26 weeks4
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.
Time frame
13 weeks, 26 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: