Status
Conditions
Treatments
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).
Full description
Prostate cancer is the most common cancer diagnosis for men in the United States. For patients with advanced or recurrent disease, ADT has is the cornerstone of systemic treatment. Overall, almost half of prostate cancer patients will undergo ADT at some point during their treatment. Unfortunately, ADT has metabolic side effects, including weight gain, central adiposity, and insulin resistance. This study is a multi-site randomized phase II trial comparing a home-delivered whole food, plant-based diet (WFPBD) with specialized behavioral coaching to standard dietary intervention with general nutritional counseling to assess the efficacy of a WFPBD in promoting weight loss in overweight/obese men receiving ADT. The home-delivered WFPBD will be for 28 days with 12 meals a week followed by 28 days with 6 meals a week; followed by self-prepared WFPBD for 18 weeks (for a total of 26 weeks).
The study hypothesis is that a WFPBD will decrease body weight and decrease systemic metabo-inflammation in overweight/obese men (BMI > 27) with prostate cancer receiving ADT. Secondary objectives will be to assess the effects of a WFPBD on adiposity, markers of inflammation (hsCRP, IL-6), metabolism (insulin, glucose, leptin, adiponectin), and fecal microbiota that may contribute to prostate cancer progression; to assess the effects of a WFPBD on quality of life; and to assess the durability of any observed effect (weight, adiposity, markers of inflammation and metabolism, fecal microbiota) of the intervention after cessation of the meal-delivery service.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
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:
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
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Loading...
Central trial contact
GUONC Research Team
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal