RESIST-ADT (Androgen Deprivation Therapy)

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485767
• Other study ID #: 20-193
• Secondary ID: R21AG065537
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: August 2023
• Source: Dana-Farber Cancer Institute
• Contact: Shehzad Basaria, MD
• Phone: 617-525-9144
• Email: sbasaria[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Physical Function
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Progressive Resistance Training Exercise
Progressive Resistance Training Exercise 2x weekly for 6 months.
• Flexibility and Balance Exercise
Flexibility and Balance Exercise Training Exercise 2x weekly for 6 months.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body composition	Lean body mass measured by dual energy x-ray absorptiometry (DEXA)	6 months
Secondary	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
Secondary	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
Secondary	Fatigue	Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F).	6 months