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

NCT03880422 | Recruiting

• 2 other identifiers: I 72118NCI-2019-00341
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Changes in muscle strength

  Baseline up to 6 months

• Changes in functional capacity muscle strength

  Baseline up to 6 months

• Change in body composition

  Baseline up to 6 months

• myokines concentration

  Baseline up to 6 months

• cytokines concentration

  Baseline up to 6 months

Other Outcomes (2)

• Serum prostate specific antigen (PSA) and androgen levels

  Up to 6 months

• Adherence to nutrition and exercise advice

  Up to 6 months

Study Arms (1)

Supportive care (diet, exercise, education)

EXPERIMENTAL

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.

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

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Receive diet plan

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Supportive care (diet, exercise, education)

Educational Intervention OTHER

Attend educational meeting

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (diet, exercise, education)

Exercise Intervention BEHAVIORAL

Complete exercise program

Supportive care (diet, exercise, education)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (diet, exercise, education)

Survey Administration OTHER

Ancillary studies

Supportive care (diet, exercise, education)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Prostatic Neoplasms

Interventions

Diet Therapy; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Ellis Levine, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellis Levine, MD

CONTACT

716-845-3159; Ellis.Levine@Roswellpark.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 19, 2019
• Study Start: May 2, 2019
• Primary Completion (Estimated): May 2, 2029
• Study Completion (Estimated): May 2, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)