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_SUPPLEMENT
    Receive diet plan
  • Educational Intervention — OTHER
    Attend educational meeting
  • Exercise Intervention — BEHAVIORAL
    Complete exercise program
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Survey Administration — OTHER
    Ancillary 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

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Ellis Levine, MD
716-845-3159
Ellis Levine, MD (PRINCIPAL_INVESTIGATOR)

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