Prostate Cancer Clinical Trial
Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors
Summary
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.
Full Description
PRIMARY OBJECTIVES:
I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT).
SECONDARY OBJECTIVES:
I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.
II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions.
III. Determine the effect of the study interventions on dietary intake, physical activity, fatigue, and quality of life.
EXPLORATORY OBJECTIVES:
I. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels.
II. Evaluate adherence to nutrition and exercise advice. III. Evaluate assessment tools and recruiting strategies.
OUTLINE:
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.
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
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
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There is 1 Location for this study
Buffalo New York, 14263, United States More Info
Principal Investigator
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