Nutrition and exercise interventions for prostate cancer survivors
Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
NA · Roswell Park Cancer Institute · NCT03880422
This study tests whether personalized nutrition and exercise plans can help prostate cancer survivors feel stronger and healthier while they are receiving hormone therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Roswell Park Cancer Institute (other) |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT03880422 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of personalized nutrition and exercise counseling in reducing obese frailty among prostate cancer survivors undergoing androgen deprivation therapy. Participants will receive tailored dietary plans and engage in a structured home-based exercise program over six months, including both aerobic and resistance training. The study aims to assess changes in myokine expression, body composition, muscle strength, and overall quality of life. Monthly educational meetings will support adherence to the interventions.
Who should consider this trial
Good fit: Ideal candidates are prostate cancer survivors currently receiving androgen deprivation therapy with no severe comorbidities.
Not a fit: Patients with significant chronic respiratory or cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the health and quality of life for prostate cancer survivors experiencing frailty due to treatment.
How similar studies have performed: Other studies have shown promising results with similar nutrition and exercise interventions in cancer survivors, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Ellis Levine, MD — Roswell Park Cancer Institute
- Study coordinator: Ellis Levine, MD
- Email: Ellis.Levine@Roswellpark.org
- Phone: 716-845-3159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer Survivor, Obesity, Overweight, Prostate Adenocarcinoma, Stage A Prostate Cancer, Stage B Prostate Cancer, Stage C Prostate Cancer, Stage D Prostate Cancer