NCT03880422 Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
| NCT ID | NCT03880422 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Cancer Survivor |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-05-02 |
| Primary Completion | 2029-05-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2019-05-02 with a primary completion date of 2029-05-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ellis Levine, MD
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT03880422 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Cancer Survivor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03880422 currently recruiting?
Yes, NCT03880422 is actively recruiting participants. Contact the research team at Ellis.Levine@Roswellpark.org for enrollment information.
Where is the NCT03880422 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT03880422 clinical trial?
NCT03880422 is sponsored by Roswell Park Cancer Institute. The principal investigator is Ellis Levine, MD at Roswell Park Cancer Institute. The trial plans to enroll 50 participants.
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