Recruiting

Nutrition & Exercise

Sponsor:

Roswell Park Cancer Institute

Code:

NCT03880422

Conditions

Cancer Survivor

Obesity

Overweight

Prostate Adenocarcinoma

Stage A Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dietary Intervention

Educational Intervention

Exercise Intervention

Quality-of-Life Assessment

Survey Administration

Study Details

Brief summary:

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.

Conditions

Cancer Survivor

Obesity

Overweight

Prostate Adenocarcinoma

Stage A Prostate Cancer

Study ID

NCT03880422

Start date

May 2, 2019

Status verified date

May, 2026

Completion date

May 2, 2029

Anticipated

Primary completion date

May 2, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Biopsy-confirmed prostate adenocarcinoma of any stage/grade
  • Prescribed or already receiving continuous ADT for < 5 years
  • Hemoglobin > 11 g/dL
  • Creatinine < 1.5 x upper limit of normal (ULN), AST or ALT <2 x ULN within 6 months prior to enrollment
  • Liver function tests < 2 x ULN
  • Able to walk unassisted at least 100 meters (200 steps) or ECOG <= 1
  • No contraindications to any aspect of participation, including aerobic exercise
  • Participant must be able to read, write, and understand the English language and be able to provide written consent
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
  • Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)
  • Overall medical frailty (clinician discretion)
  • Any condition contraindicating additional blood collection beyond standard of care
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Dietary Intervention

Receive diet plan

Educational Intervention

Attend educational meeting

Exercise Intervention

Complete exercise program

Quality-of-Life Assessment

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • Changes in body composition [ Time Frame: Baseline up to 6 months ]

Central Contacts and Locations

Central contacts

Ellis Levine, MD

716-845-3159Ellis.Levine@Roswellpark.org

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Ellis Levine, MD

716-845-3159Ellis.Levine@roswellpark.org

Principal Investigator:

Ellis Levine, MD

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-05-07.