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

Korábbi kezelés

• Concurrent participation in other nutrition or weight loss programs
• Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention

Más betegség

• Insulin-dependent diabetes mellitus
• Nut or legume allergy, gluten intolerance or celiac disease
• Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
• 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
• Diagnosed, active inflammatory bowel disease

Laborértékek

• Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin

Egyéb

• Currently consuming a vegetarian or vegan diet
• Expected changes in exercise patterns during the study period
• Ongoing use of warfarin anticoagulants
• Inability to receive Emails or have a smart phone

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• 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.
• 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
• 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
• At least 3 months post completion of chemotherapy and/or radiation
• Bone resorptive agents such as bisphosphanates and denosumab are allowed.
• Testosterone level <50 ng/dL
• Age ≥ 45 years
• BMI ≥ 27
• ECOG performance status of 0 to 1
• Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
  • White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L)
  • Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion
  • Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
  • 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.
  • Serum albumin ≥ 2.8 g/dl
• Willingness and ability to comply with all study-related procedures
• Capable of understanding and complying with the protocol requirements and must have signed the informed consent document