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

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 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.

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)

- 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)

- 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