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Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors
RECRUITINGN/ASponsored by Roswell Park Cancer Institute
Actively Recruiting
PhaseN/A
SponsorRoswell Park Cancer Institute
Started2019-05-02
Est. completion2029-05-02
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03880422
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
Age: 18 Years+Sex: MALEHealthy volunteers 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
Conditions21
CancerCancer SurvivorObesityOverweightProstate AdenocarcinomaStage A Prostate CancerStage B Prostate CancerStage C Prostate CancerStage D Prostate CancerStage I Prostate Cancer
Locations1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
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Actively Recruiting
PhaseN/A
SponsorRoswell Park Cancer Institute
Started2019-05-02
Est. completion2029-05-02
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03880422