Whole Food Plant-based Diet to Improve Outcomes in 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
• Alcohol and/or drug abuse

Más betegség

• Nut or legume allergy
• Insulin-dependent or requiring diabetes mellitus
• Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
• Diagnosed, active inflammatory bowel disease
• Psychiatric illnesses or social situations that would limit compliance with study requirements including the inability or lack of equipment to perform basic cooking tasks

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
• Active prostatitis
• Ongoing use of warfarin anticoagulants

• Males 45-99 years of age
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Increasing PSA on at least 2 sequential tests not more than 6 months apart.
• Eastern Cooperative Oncology Group Performance Status Scale of 0 to 2
• 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 ≥ 50,000/mm3 (≥ 100 GI/L) without transfusion
  • Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x upper limit of normal (or for subjects with Gilbert's syndrome direct bilirubin WNL) 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