Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jul 19, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a whole-food, plant-based diet can help control weight and inflammation in overweight or obese men who have prostate cancer and are receiving hormone therapy. The study is comparing the effects of delivering healthy, plant-based meals to participants at home against standard nutritional advice. This trial is currently seeking male participants aged 45 and older who have been diagnosed with prostate cancer and are undergoing hormone treatment.

To be eligible for the trial, participants must have a confirmed diagnosis of prostate cancer and have been on hormone therapy for at least 24 weeks. They should also have a body mass index (BMI) of 27 or higher, which is a measure of weight in relation to height. Participants can expect to receive meals delivered to their homes and guidance throughout the study to help them stick to the diet. It’s important for potential participants to be willing to follow the study's requirements and to have a living situation that allows for meal delivery. This trial offers an opportunity to explore how dietary changes may improve health during cancer treatment.

Gender

MALE

Eligibility criteria

• • Inclusion Criteria
• • 1. Histologically or cytologically confirmed adenocarcinoma of the prostate
• • 2. Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible.
• • 3. On ADT for at least 24 weeks pre-study with anticipation of at least 26 more weeks of therapy from the date of initiation of the dietary intervention
• • 4. Patients receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) are eligible if they have been on therapy for at least 3 months and plan to continue for the duration of the study
• • 5. At least 3 months post completion of chemotherapy and/or radiation
• • 6. Bone resorptive agents such as bisphosphanates and denosumab are allowed.
• • 7. Testosterone level \<50 ng/dL
• • 8. Age ≥ 45 years
• • 9. BMI ≥ 27
• • 10. ECOG performance status of 0 to 1
• 11. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
• • 1. White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L)
• • 2. Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion
• • 3. Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
• • 4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x ULN (or for subjects with Gilbert's disease direct bilirubin WNL) Note: Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (up to 5x ULN) will be eligible if elevation is felt to be due to fatty liver disease related to obesity.
• • 5. Serum albumin ≥ 2.8 g/dl
• • 12. Willingness and ability to comply with all study-related procedures
• • 13. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
• • Exclusion Criteria
• • 1. Insulin-dependent diabetes mellitus
• • 2. Nut or legume allergy, gluten intolerance or celiac disease
• • 3. Currently consuming a vegetarian or vegan diet
• • 4. Concurrent participation in other nutrition or weight loss programs
• • 5. Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
• • 6. Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
• • 7. Expected changes in exercise patterns during the study period
• • 8. Psychiatric illnesses or social situations that would limit compliance with study requirements, including a living situation that does not allow for the delivery of Plantable prepared meals, or the inability or lack of equipment to perform basic cooking tasks
• • 9. Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
• • 10. Ongoing use of warfarin anticoagulants
• • 11. Diagnosed, active inflammatory bowel disease
• • 12. Inability to receive Emails or have a smart phone