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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03880422.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Active
Contact: Gurkamal S. Chatta
Phone: 716-845-3117
PRIMARY OBJECTIVE:
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. During this time, patients wear a Fitbit to track physical activity. Patients also attend monthly educational meetings for 6 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorGurkamal S. Chatta