Actively Recruiting
Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-05-07
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how personalized nutrition and exercise programs can help reduce obese frailty caused by androgen deprivation therapy (ADT) in prostate cancer survivors. The trial aims to study changes in body composition and myokine levels in the blood, as well as effects on muscle strength, respiratory muscle strength, functional capacity, inflammation, fatigue, diet, physical activity, and quality of life. The study also explores the relationship of these changes with prostate specific antigen (PSA) and testosterone levels, adherence to the interventions, and recruitment methods. Participants receive a customized diet plan for six months alongside a home-based exercise program that includes aerobic and resistance exercises performed 3 or more days per week for 10 to 30 minutes daily. Additionally, they follow a progressive resistance exercise routine targeting major muscle groups 5 days a week. Monthly educational meetings are held over the 6-month period to support and guide participants. During the study, participants are assessed for changes in body composition, muscle and respiratory strength, functional capacity, blood myokines and cytokines, dietary intake, physical activity, fatigue, and quality of life. These measures are taken from baseline through the 6-month intervention period. The trial monitors adherence to the nutrition and exercise plans and collects survey and quality-of-life data to evaluate the overall impact of the interventions on prostate cancer survivors receiving ADT.
CONDITIONS
Brief Title
Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed prostate adenocarcinoma of any stage or grade
- Prescribed or already receiving continuous androgen deprivation therapy for less than 5 years
- Hemoglobin level greater than 11 g/dL
- Creatinine less than 1.5 times the upper limit of normal, and AST or ALT less than 2 times the upper limit of normal within 6 months prior to enrollment
- Liver function tests less than 2 times the upper limit of normal
- Able to walk unassisted for at least 100 meters (about 200 steps) or Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- No contraindications to any part of the study, including aerobic exercise
- Able to read, write, and understand English and provide written informed consent
- Understand the investigational nature of the study and sign an approved consent form before any study procedures
You will not qualify if you...
- Known severe chronic obstructive pulmonary disease, ischemic heart disease, congestive heart failure, or significant cardiac arrhythmias
- Limiting orthopedic, musculoskeletal, or psychological conditions as determined by a clinician
- Overall medical frailty as determined by a clinician
- Any condition preventing additional blood collection beyond standard care
- Unwilling or unable to follow the study protocol
- Any condition that the investigator considers makes the participant unsuitable for the study intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive an individualized diet plan and complete a home-based exercise program including aerobic and resistance exercises. They also attend monthly educational meetings over the course of 6 months.
Monthly visits for educational meetings
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
E
Ellis Levine, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here