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RESIST-ADT (Androgen Deprivation Therapy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04485767
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : August 15, 2023
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Shehzad Basaria, MD, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Physical Function Behavioral: Progressive Resistance Training Exercise Behavioral: Flexibility and Balance Exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Preventing a Decline in Physical Function in Older Androgen-Deprived Men With Structured Exercise Training (RESIST-ADT Trial)
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 6 months ]
    Lean body mass measured by dual energy x-ray absorptiometry (DEXA)

  2. 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.

  3. 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

  4. Fatigue [ Time Frame: 6 months ]
    Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485767


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

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02066
Contact: Shehzad Basaria, MD    617-525-9144    sbasaria@bwh.harvard.edu   
Contact: Milena Braga, MD    617-525-9144    mbraga2@bwh.harvard.edu   
Principal Investigator: Shehzad Basaria, MD         
Principal Investigator: Thomas Storer, PhD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Shehzad Basaria, MD    617-525-9144    sbasaria@bwh.harvard.edu   
Contact: Milena Braga, MD    617-525-9144    mbraga2@bwh.harvard.edu   
Principal Investigator: Shehzad Basaria, MD         
Principal Investigator: Thomas Storer, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Shehzad Basaria, MD Brigham and Women's Hospital
Principal Investigator: Thomas Storer, PhD Brigham and Women's Hospital
More Information
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Responsible Party: Shehzad Basaria, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04485767    
Other Study ID Numbers: 20-193
R21AG065537 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shehzad Basaria, MD, Dana-Farber Cancer Institute:
Prostate Cancer
Androgen Deprivation Therapy (ADT)
Physical Function
Structured Exercise
Muscle Strength and Power
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases