Clinical trial NCT04485767: RESIST-ADT (Androgen Deprivation Therapy)
Official title: Preventing a Decline in Physical Function in Older Androgen-Deprived Men With Structured Exercise Training (RESIST-ADT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Physical Function
Keywords: Prostate Cancer
Androgen Deprivation Therapy (ADT)
Physical Function
Structured Exercise
Muscle Strength and Power
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-07-24
Enrollment: 21
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Structured Resistance Exercise vs Control Exercise
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Loaded stair climb power
timeFrame: 6 months
Secondary outcomes:
measure: Body composition
timeFrame: 6 months
measure: Muscle strength and power
timeFrame: 6 months
measure: Quality of Life (QOL)
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shehzad Basaria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Thomas Storer, PhD
role: PRINCIPAL_INVESTIGATOR
References: