Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
Recruiting · NCT03880422 · Interventional (participants receive a specific treatment) · Lead sponsor: Roswell Park Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Dietary InterventionEducational InterventionExercise InterventionQuality-of-Life AssessmentSurvey Administration
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 1 US state.
- Roswell Park Cancer Institute - Buffalo, New York, United States
- Roswell Park Cancer Institute - Buffalo, New York, United States