Active, not recruitingNot applicableInterventional
What this study is about
The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age45 Years to 99 Years
SexMale
Healthy volunteersNot accepted
ConditionProstate Cancer
Full registry 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
Treatments and study arms
Whole-food, Plant-Based Diet
Behavioral
Pre-packaged, freshly made plant-based meals (provided by either Plantable or CookUnity) will be delivered weekly to participants' homes for 8 weeks. Meals are made with whole ingredients including whole grains, vegetables, legumes, nuts and seeds. Added sugar, animal-based products, refined grains, and processed foods are not used in any meal. Participants will be coached via phone calls, SMS, emails, and the app throughout the intervention to prepare meals in accordance with the diet. Participants will have access to a Registered Dietitian. During the first 4 weeks, 12 meals/week will be provided to participants; followed by 6 meals/week for the next 4 weeks; followed by 18 weeks where participants will continue to receive coaching, but will be expected to make all their own whole-food, plant-based meals with staff assistance available.
General Nutritional Counseling
Behavioral
All study participants will receive consult with a Registered Dietitian at the Baseline visit and visit 1 study assessments. After visit 1, study participants assigned to the general nutritional counseling arm will receive an additional in-person or telehealth consultation with a Registered Dietitian that will consist of identification and counseling to improve diet quality and achieve a healthy body weight consistent with American Cancer Society guidelines. Study participants in the control group will continue to receive general nutritional counseling and education with weekly scheduled telephone consultations with a Registered Dietitian for the first 4 weeks of the study period. For the remainder of the study period, they will receive counseling and education from Registered Dietitians via monthly scheduled phone calls.
