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Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer
This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.
PRIMARY OBJECTIVES: I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT). SECONDARY OBJECTIVES: I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions. II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions. III. Determine the effect of the study interventions on dietary intake, physical activity, fatigue, and quality of life. EXPLORATORY OBJECTIVES: I. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels. II. Evaluate adherence to nutrition and exercise advice. III. Evaluate assessment tools and recruiting strategies. OUTLINE: Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Roswell Park Cancer Institute
Buffalo, New York, United States
Start Date
May 2, 2019
Primary Completion Date
May 2, 2029
Completion Date
May 2, 2029
Last Updated
October 2, 2025
50
ESTIMATED participants
Dietary Intervention
DIETARY_SUPPLEMENT
Educational Intervention
OTHER
Exercise Intervention
BEHAVIORAL
Quality-of-Life Assessment
OTHER
Survey Administration
OTHER
Lead Sponsor
Roswell Park Cancer Institute
NCT07472881
NCT01143454
Data Source & Attribution
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