Clinical trial
Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
Recruiting now · Not applicable · 1 countries · Registry ID NCT03880422
Recruiting nowNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexMale
Healthy volunteersNot accepted
ConditionCancer 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
Full registry 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
Treatments and study arms
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
Primary outcomes
Changes in body compositionBaseline up to 6 months
Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Roswell Park Cancer Institute🇺🇸 Buffalo, New York, United States
Ellis Levine, MDContact
Ellis Levine, MDPrincipal Investigator