Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- Roswell Park Cancer Institute
- Study ID
- NCT03880422
- Status
- Recruiting
Conditions
- Cancer Survivor
- Obesity
- Overweight
- Prostate Adenocarcinoma
- Stage A Prostate Cancer
- Stage B Prostate Cancer
- Stage C Prostate Cancer
- Stage D Prostate Cancer
- Stage I Prostate Cancer
- Stage II Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
- Stage IIC Prostate Cancer
- Stage III Prostate Cancer
- Stage IIIA Prostate Cancer
- Stage IIIB Prostate Cancer
- Stage IIIC Prostate Cancer
- Stage IV Prostate Cancer
- Stage IVA Prostate Cancer
- Stage IVB Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dietary Intervention — DIETARY_SUPPLEMENTReceive diet plan
- Educational Intervention — OTHERAttend educational meeting
- Exercise Intervention — BEHAVIORALComplete exercise program
- Quality-of-Life Assessment — OTHERAncillary studies
- Survey Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- May 2, 2019
- Status verified
- May 2026
- Primary completion
- May 2, 2029
- Completion
- May 2, 2029
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Supportive care (diet, exercise, education)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.
Primary Outcome Measure
Changes in body composition [ Time Frame: Baseline up to 6 months ]
Central Contacts
- Ellis Levine, MD716-845-3159
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Ellis Levine, MD (PRINCIPAL_INVESTIGATOR) |
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