Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Launched by ROSWELL PARK CANCER INSTITUTE · Mar 15, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how nutrition and exercise can help prostate cancer survivors who are experiencing weight-related health issues due to a treatment called androgen deprivation therapy (ADT). The goal is to see if personalized diet and exercise plans can reduce problems related to being overweight and improve certain health markers in the blood. This study is currently recruiting male participants aged 65 to 74 who have been diagnosed with prostate cancer and are undergoing ADT for less than five years.

To be eligible for the trial, participants must have a confirmed diagnosis of prostate cancer, be able to walk at least 100 meters without assistance, and meet certain health criteria, such as having stable blood tests. Those with serious heart or lung issues, or other conditions that may affect their ability to participate, will not be eligible. If you join the study, you can expect to receive tailored nutrition and exercise advice, and you’ll be contributing to important research that may help other prostate cancer survivors in the future.

Gender

MALE

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