Clinical trial NCT05471414: Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
Official title: Whole-Food Plant-Based Diet (WFPBD) to Control Weight and Metabo-Inflammation in Overweight/Obese Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT): A Multi-Center Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Plantable Inc.
name: Prostate Cancer Foundation
name: CookUnity
First posted: 2022-07-22
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

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

Primary outcomes:
measure: Change in weight from baseline to 4 weeks post-randomization
timeFrame: Baseline; 4 weeks post-randomization
Secondary outcomes:
measure: Change in levels of serum hsCRP from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of serum IL-6 from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of serum glucose from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of serum leptin from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of serum adiponectin from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of serum direct LDL from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of HDL from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of fasting triglycerides from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in levels of serum insulin from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in FACT-P score as an indicator of quality of life from baseline to 4, 8, and 26
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in mean measures of body fat percentage, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization
timeFrame: Baseline; 4 weeks and 26 weeks post-randomization
measure: Change in the diversity of the fecal microbiome from baseline to 4 and 26 weeks post-randomization
timeFrame: Baseline; 4 weeks and 26 weeks post-randomization
measure: Change in mean fat free body mass, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization.
timeFrame: Baseline; 4 weeks and 26 weeks post-randomization
measure: Change in mean body mass including fat, as determined by DEXA scan, from baseline to 4 and 26 weeks post-randomization.
timeFrame: Baseline; 4 weeks and 26 weeks post-randomization
measure: Change in levels of hemoglobin A1c from baseline to 4, 8, and 26 weeks post-randomization
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
measure: Change in BMI from baseline to 4, 8, and 26 weeks post-randomization.
timeFrame: Baseline; 4, 8, and 26 weeks post-randomization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: David M Nanus, MD
role: PRINCIPAL_INVESTIGATOR
References: