Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight; Cancer Survivor; Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage IVA Prostate Cancer; Stage IVB Prostate Cancer; Stage A Prostate Cancer; Stage B Prostate Cancer; Stage C Prostate Cancer; Stage D Prostate Cancer; Stage IIC Prostate Cancer; Stage IIIA Prostate Cancer; Stage IIIB Prostate Cancer; Stage IIIC Prostate Cancer
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Survey Administration; Dietary supplement: Dietary Intervention; Other: Educational Intervention; Behavioral: Exercise Intervention

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellis Levine, MD; Phone Number: 716-845-3159; Email: Ellis.levine@RoswellPark.org

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
      • Principal Investigator: Ellis Levine, MD
      • Contact: Ellis Levine, MD; Phone Number: 716-845-3159; Email: Ellis.levine@RoswellPark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Survey Administration; Ancillary studies; Dietary supplement: Dietary Intervention; Receive diet plan; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Educational Intervention; Attend educational meeting; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Exercise Intervention; Complete exercise program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscle strength	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).	Baseline up to 6 months
Changes in functional capacity muscle strength	Improvement of muscle strenght	Baseline up to 6 months
Change in body composition	All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition	Baseline up to 6 months
myokines concentration	Will be assessed by serum biomarker levels.	Baseline up to 6 months
cytokines concentration	Will be assessed by serum biomarker levels.	Baseline up to 6 months
Health related quality of life Short Form	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	Up to 6 months
Changes in dietary intake	Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.	Baseline up to 6 months
Changes in physical activity	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.	Baseline up to 6 months
Change in fatigue	Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.	Baseline up to 6 months
Change in Respiratory Muscle Strength	Mouth pressure device	Baseline up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum prostate specific antigen (PSA) and androgen levels	Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels.	Up to 6 months
Adherence to nutrition and exercise advice	Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.	Up to 6 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Ellis Levine, MD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Estimated): May 2, 2029
• Study Completion (Estimated): May 2, 2029

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Nutrition Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Prostatic Neoplasms; Overweight; Obesity; Investigative Techniques; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Nutrition Therapy; Methods; Early Intervention, Educational; Educational Status; Diet Therapy
• Other Study ID Numbers: I 72118 (Other Identifier: Roswell Park Cancer Institute); NCI-2019-00341 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No