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

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Stage B Prostate Cancer; Stage IVA Prostate Cancer; Stage IIIA Prostate Cancer; Obesity; Cancer Survivor; Stage D Prostate Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer; Stage IIIC Prostate Cancer; Stage IIB Prostate Cancer; Stage IIIB Prostate Cancer; Stage II Prostate Cancer; Overweight; Stage IV Prostate Cancer; Prostate Adenocarcinoma; Stage IIC Prostate Cancer; Stage IVB Prostate Cancer; Stage IIA Prostate Cancer; Stage A Prostate Cancer; Stage C Prostate Cancer

Treatments: Other: Survey Administration; Other: Quality-of-Life Assessment; Behavioral: Exercise Intervention; Other: Educational Intervention; Dietary Supplement: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03880422

NCI-2019-00341 (Registry Identifier)

I 72118 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Supportive care (diet, exercise, education)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary Intervention

Behavioral: Exercise Intervention

Other: Educational Intervention

Other: Quality-of-Life Assessment

Other: Survey Administration