Last Verified: | June/30/2020 |
First Submitted: | February/28/2019 |
Estimated Enrollment Submitted: | March/14/2019 |
First Posted: | March/18/2019 |
Last Update Submitted: | July/6/2020 |
Last Update Posted: | July/7/2020 |
Actual Study Start Date: | January/2/2019 |
Estimated Primary Completion Date: | January/2/2021 |
Estimated Study Completion Date: | January/2/2022 |
Study Type: | Interventional |
Allocation: | N/A |
Primary Purpose: | Supportive Care |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: Supportive care (diet, exercise, education) Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months. | Dietary Supplement: Supportive care (diet, exercise, education) Receive diet plan |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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 - Body mass index (BMI) > 25.0 (overweight and obese) - 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) - Patients on ADT with concurrent chemotherapy, immunotherapy and/or radiotherapy. Palliative radiation okay. - 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 |