RESIST-ADT (Androgen Deprivation Therapy)

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ClinicalTrials.gov Identifier: NCT04485767

Recruitment Status : Recruiting

First Posted : July 24, 2020

Last Update Posted : August 15, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

National Institute on Aging (NIA)

Information provided by (Responsible Party):

Shehzad Basaria, MD, Dana-Farber Cancer Institute

Tracking Information

First Submitted Date ^ICMJE

July 22, 2020

First Posted Date ^ICMJE

July 24, 2020

Last Update Posted Date

August 15, 2023

Actual Study Start Date ^ICMJE

December 1, 2020

Estimated Primary Completion Date

July 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Loaded stair climb power [ Time Frame: 6 months ]

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.

Original Primary Outcome Measures ^ICMJE

Loaded stair climb change [ Time Frame: Baseline, 3 and 6-month ]

Change History

Current Secondary Outcome Measures ^ICMJE

Body composition [ Time Frame: 6 months ]
Lean body mass measured by dual energy x-ray absorptiometry (DEXA)
Muscle strength and power [ Time Frame: 6 months ]
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.
Quality of Life (QOL) [ Time Frame: 6 months ]
Measured by SF-36 questionnaire a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being
Fatigue [ Time Frame: 6 months ]
Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F).

Original Secondary Outcome Measures ^ICMJE

Lean mass [ Time Frame: Baseline, 3 and 6-month ]
Measured by DEXA scan
Leg press strength [ Time Frame: Baseline, 3 and 6-month ]
Measured by 1RM method
Quality of Life (QOL) [ Time Frame: Baseline, 3 and 6-month ]
Measured by SF-36 questionnaire
Fatigue [ Time Frame: Baseline, 3 and 6-month ]
Measured by FACIT-F questionnaire

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

RESIST-ADT (Androgen Deprivation Therapy)

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Structured Resistance Exercise vs Control Exercise

Masking: Double (Participant, Investigator)
Masking Description:

Participants, Investigators and Research Staff will remain blinded.

Only exercise personnel and study statistician will be unblinded.

Primary Purpose: Supportive Care

Condition ^ICMJE

Prostate Cancer
Physical Function

Intervention ^ICMJE

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

Study Arms ^ICMJE

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.

Intervention: Behavioral: Progressive Resistance Training Exercise
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.

Intervention: Behavioral: Flexibility and Balance Exercise

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

October 31, 2024

Estimated Primary Completion Date

July 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:	Male
Gender Based Eligibility:	Yes

Ages ^ICMJE

60 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Shehzad Basaria, MD	617-525-9144	sbasaria@bwh.harvard.edu
Contact: Milena Braga, MD	617-525-9144	mbraga2@bwh.harvard.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04485767

Other Study ID Numbers ^ICMJE

20-193
R21AG065537 ( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
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.
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Informed Consent Form (ICF)
Time Frame:	Data can be shared no earlier than 1 year following the date of publication
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