RESIST-ADT (Androgen Deprivation Therapy)

Preventing a Decline in Physical Function in Older Androgen-Deprived Men With Structured Exercise Training (RESIST-ADT Trial)

The overall goal of this study is to determine if implementing structured exercises prevent decline in muscle mass, muscle strength and physical function in men with prostate cancer undergoing androgen deprivation therapy (ADT). Our main hypothesis is that structured resistance exercise training in men undergoing ADT will preserve physical function assessed by loaded stair climbing power compared with the control group. The trial will also examine the efficacy of the exercise regimen on muscle strength, QOL and fatigue. The findings of this trial will lay the groundwork for definitive intervention trials to prevent frailty and falls in these men.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Physical Function
• Intervention / Treatment: Behavioral: Progressive Resistance Training Exercise; Behavioral: Flexibility and Balance Exercise

Detailed Description

This randomized, controlled, parallel group trial of 6-months duration is determining the efficacy of structured resistance exercise training in preventing the decline in physical function in older men with prostate cancer undergoing androgen deprivation therapy (ADT). It will compare the structured resistance exercise training with a control group of men undergoing flexibility and balance exercises training.

Men undergoing ADT for treatment of their prostate cancer experience a significant decline in muscle mass and muscle strength, which impacts their physical function. This predisposes them to frailty and a higher risk of falls. In addition to physical dysfunction, men undergoing ADT also experience a significant decrease in health-related quality of life and experience fatigue (tiredness).

This research study is taking a preventative approach to the physical function problems in men with prostate cancer by implementing exercise interventions before participants begin ADT that are specifically designed to improve muscle mass, muscle strength and physical function to lessen the impacts of muscle mass and strength decline.

The study includes a screening visit during which the following procedures will be conducted: Vitals, EKG, blood sample collection and a physical to determine eligibility. If qualified, participants will be randomly assigned to two different types of structured exercises: Resistance exercise training or flexibility and balance exercises. During the weekly exercise training 20 subjects will be assigned to the Exercise A group and 20 subjects to the Exercise B group. The exercise training sessions will occur approximately 2 times/week. In addition participants will also undergo DEXA scans, perform muscle strength testing and complete questionnaires at baseline, 3- and 6-month visits.

It is expected participants will be in this research study for up to 6 months. It is expected that about 40 people will take part in this research study.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shehzad Basaria, MD; Phone Number: 617-525-9144; Email: sbasaria@bwh.harvard.edu
• Study Contact Backup: Name: Milena Braga, MD; Phone Number: 617-525-9144; Email: mbraga2@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Shehzad Basaria, MD; Phone Number: 617-525-9144; Email: sbasaria@bwh.harvard.edu
      • Principal Investigator: Thomas Storer, PhD
      • Principal Investigator: Shehzad Basaria, MD
      • Contact: Milena Braga, MD; Phone Number: 617-525-9144; Email: mbraga2@bwh.harvard.edu
    • Boston, Massachusetts, United States, 02066
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Shehzad Basaria, MD; Phone Number: 617-525-9144; Email: sbasaria@bwh.harvard.edu
      • Principal Investigator: Thomas Storer, PhD
      • Principal Investigator: Shehzad Basaria, MD
      • Contact: Milena Braga, MD; Phone Number: 617-525-9144; Email: mbraga2@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men with active Prostate Cancer who are 60 years or older.
• Hormone-naive men about to undergo medical or surgical ADT.
• Planned ADT for at least 6 months.
• Life expectancy of at least 6 months from enrollment.
• Ability and willingness to provide informed consent.

Exclusion Criteria:

• Active medical conditions affecting participation in exercise training (limiting arthropathies, myopathies, severe peripheral vascular disease, or severe neuropathy).
• Cardiovascular disease (current angina, severe valvular disease, advanced congestive heart failure, arrhythmias, or stroke with residual muscular weakness).
• Prior hip or knee replacement.
• History of lower extremity fracture in the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progressive Resistance Training Exercise; Men with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend structured progressive resistance exercise training sessions 2 times/week for six months.	Behavioral: Progressive Resistance Training Exercise; Progressive Resistance Training Exercise 2x weekly for 6 months.
Active Comparator: Flexibility and Balance Exercise; Men with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend flexibility and balance exercises training sessions 2 times/week for six months.	Behavioral: Flexibility and Balance Exercise; Flexibility and Balance Exercise Training Exercise 2x weekly for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loaded stair climb power	Compare the efficacy of a structured resistance exercise regimen vs a structured control regimen on loaded stair climb power. Assessment of physical function as measured by Loaded Stair Climbing Power.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Lean body mass measured by dual energy x-ray absorptiometry (DEXA)	6 months
Muscle strength and power	Maximal voluntary muscle strength in the lower extremities will be assessed by conducting the leg and chest press exercise by the 1-repetition maximum method and assessing loaded stair climb power.	6 months
Quality of Life (QOL)	Measured by SF-36 questionnaire a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being	6 months
Fatigue	Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F).	6 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Thomas Storer, PhD, Brigham and Women's Hospital; Principal Investigator: Shehzad Basaria, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Prostate Cancer; Physical Function; Androgen Deprivation Therapy (ADT); Structured Exercise; Muscle Strength and Power
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20-193; R21AG065537 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No