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

Not Applicable

Recruiting

• Conditions: Stage A Prostate Cancer; Stage III Prostate Cancer; Stage IIIB Prostate Cancer; Stage IV Prostate Cancer; Obesity; Stage C Prostate Cancer; Stage II Prostate Cancer; Stage IIB Prostate Cancer; Stage IIC Prostate Cancer; Stage IIIA Prostate Cancer
• Interventions: Dietary Supplement: Dietary Intervention; Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration

• Registration Number: NCT03880422
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Study Start: 2019-05-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-04
• Primary Completion: 2029-05-02
• Study Completion: 2029-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (diet, exercise, education)	Exercise Intervention	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.
Supportive care (diet, exercise, education)	Survey Administration	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.
Supportive care (diet, exercise, education)	Dietary Intervention	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.
Supportive care (diet, exercise, education)	Educational Intervention	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.
Supportive care (diet, exercise, education)	Quality-of-Life Assessment	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.

Primary Outcome Measures

Name	Time	Method
Changes in body composition	Baseline up to 6 months	Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.

Secondary Outcome Measures

Name	Time	Method
cytokines concentration	Baseline up to 6 months	Will be assessed by serum biomarker levels.
Changes in functional capacity muscle strength	Baseline up to 6 months	Improvement of muscle strenght
Changes in physical activity	Baseline up to 6 months	Will be assessed by Godin Leisure Time survey and Fitbit activity report. Will be summarized by time point using the observed sample size, mean, and standard deviation. Will be evaluated using a two-sided permutation paired t-test. Additionally, the mean change in each outcome will be estimated using a 95% confidence interval. As exploratory analyses, the association between the change in each outcome and demographic/clinical factors may be evaluated using general linear models. The change in outcome will be modeled as a function of baseline levels and each demographic/clinical factor in a one-at-a-time manner.
Changes in muscle strength	Baseline up to 6 months	Will be assessed by chest press, leg press, grip strength,6-minute walk test, timed-up-and-go, agility, Berg balance scale, short physical performance battery (SPPB).
Change in body composition	Baseline up to 6 months	All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition
myokines concentration	Baseline up to 6 months	Will be assessed by serum biomarker levels.
Changes in dietary intake	Baseline up to 6 months	Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.
Change in Respiratory Muscle Strength	Baseline up to 6 months	Mouth pressure device
Health related quality of life Short Form	Up to 6 months	Will be used to assess quality of life . The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, Lower scores = more disability, higher scores = less disability
Change in fatigue	Baseline up to 6 months	Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States