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Official title Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT03880422
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or...
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.