Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT07189702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plant-Based Nutrition for Breast or Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Dietary Adherence at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': '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.'}, {'measure': 'Mean Change in Participant Retention at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Disease-Specific Quality of Life - FACT-B at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': '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.'}, {'measure': 'Mean Change in Disease-Specific Quality of Life - FACT-En at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': '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.'}, {'measure': 'Mean Change in Cognitive Dysfunction (FACT-COG) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': '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.'}, {'measure': 'Mean Change in Cancer-Related Fatigue (BFI) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': '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.'}, {'measure': 'Mean Change in General Symptoms (MDASI) at 13 and 26 Week', 'timeFrame': '13 weeks, 26 weeks', 'description': '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.'}, {'measure': 'Overall Survival at Close of Study', 'timeFrame': 'End of study (26 weeks)', 'description': '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.'}, {'measure': 'Mean Change in Cardiometabolic Marker (Weight) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Weight is collected at each time point, and mean change from baseline is calculated.'}, {'measure': 'Mean Change in Cardiometabolic Marker (Lipids) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Lipids are measured at each time point, and mean change from baseline is calculated.'}, {'measure': 'Mean Change in Cardiometabolic Marker (Blood Pressure) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Blood Pressure is measured at each time point, and mean change from baseline is calculated.'}, {'measure': 'Mean Change in Cardiometabolic Marker (Insulin) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Insulin is measured at each time point, and mean change from baseline is calculated.'}, {'measure': 'Mean Change in Cardiometabolic Marker (Inflammation) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Inflammation is measured at each time point, and mean change from baseline is calculated.'}, {'measure': 'Mean Change in Cardiometabolic Marker (Blood Glucose) at 13 and 26 Weeks Description:', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Blood Glucose is measured at each time point, and mean change from baseline is calculated.'}, {'measure': 'Mean Change in Hormonal Marker (IGF1) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Description: IGF1 is measured at each time point, and mean change from baseline is calculated.'}, {'measure': 'Mean Change in Hormonal Marker (sex hormones) at 13 and 26 Weeks', 'timeFrame': '13 weeks, 26 weeks', 'description': 'Sex hormones are measured at each time point, and mean change from baseline is calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic', 'Metastatic Breast', 'Metastatic Endometrial', 'Breast Stage IV', 'Endometrial Stage IV', 'Nutrition', 'Plant-Based Nutrition'], 'conditions': ['Breast Cancer Metastatic', 'Endometrial Cancer Stage IV']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: • Female sex (as assigned at birth), aged 18 years or older\n\n* A confirmed diagnosis of endometrial or metastatic breast cancer. All subtypes are eligible\n* Treating oncologist approval and expected survival of at least six months\n* 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.\n* Willing to adopt a strict, whole-foods, plant-based diet\n* Willing and able to comply with the WFPB protocol for the duration of the study including scheduled testing, Zoom meetings, and office visits\n* Able to speak and read English fluently.\n* Women with plans for radiation therapy or surgery are also eligible provided that they meet all other eligibility criteria.\n\nExclusion Criteria: • BMI ≤ 20.0 kg/m2\n\n* Inability to tolerate a normal diet\n* Active malabsorption syndrome at time of consent, as determined by study physicians (i.e. Crohn's disease, bowel surgery)\n* Any food allergies or intolerances that would interfere with study compliance\n* Recent consumption (in the past six months) of a vegan diet\n* eGFR \\< 30 on ≥ two lab tests in the past six months\n* Serum potassium \\> 5.4 in the past six months\n* Current insulin or sulfonylurea use\n* Current warfarin use (non-vitamin K antagonist allowed)\n* High-risk alcohol use (\\>7 drinks/wk)\n* Illicit substance use (not including marijuana)\n* Cognitive impairment or psychiatric disorder impairing ability to give consent."}, 'identificationModule': {'nctId': 'NCT07189702', 'acronym': 'BEND-MBEC', 'briefTitle': 'Plant-Based Nutrition for Breast or Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Randomized Controlled Trial of Behavioral Education and Nutrition Delivery in Women With Metastatic Breast and Endometrial Cancer. (The BEND-MBEC Study)', 'orgStudyIdInfo': {'id': 'STUDY00010949'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Regular Diet with Cancer-Related Wellness Education and Support', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Whole Food, Plant-Based Diet with Behavioral Education and Support', 'description': 'Whole Food, Plant-Based Diet with Behavioral Education and Support', 'interventionNames': ['Other: Whole Food, Plant-Based Diet with Behavioral Education and Support']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'Regular Diet with Cancer-Related Wellness Education and Support', 'armGroupLabels': ['Control']}, {'name': 'Whole Food, Plant-Based Diet with Behavioral Education and Support', 'type': 'OTHER', 'description': 'Whole Food, Plant-Based Diet with Behavioral Education and Support', 'armGroupLabels': ['Whole Food, Plant-Based Diet with Behavioral Education and Support']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lisa M Blanchard, BS', 'role': 'CONTACT', 'email': 'lisa_blanchard@urmc.rochester.edu', 'phone': '585-953-6709'}, {'name': 'Erin k Campbell, MD,MPH', 'role': 'CONTACT', 'email': 'Erin_Campbell@urmc.rochester.edu', 'phone': '585-602-0477'}], 'overallOfficials': [{'name': 'Thomas M Campbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Erin K Campbell, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor (Part-Time) - Department of Family Medicine (SMD)', 'investigatorFullName': 'Thomas M Campbell', 'investigatorAffiliation': 'University of Rochester'}}}}