Prostate CancerNCT04485767
RESIST-ADT (Androgen Deprivation Therapy)
A study testing Progressive Resistance Training Exercise and Flexibility and Balance Exercise in people with Prostate Cancer and Physical Function, run by Dana-Farber Cancer Institute at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Prostate Cancer, Physical Function
- What is being tested?
- Progressive Resistance Training Exercise and Flexibility and Balance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02066
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Physical Function
- Being tested
- Progressive Resistance Training Exercise, Flexibility and Balance Exercise
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy (ADT), Physical Function, Structured Exercise, Muscle Strength and Power
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance Training ExerciseBehavioural
Progressive Resistance Training Exercise 2x weekly for 6 months.
Flexibility and Balance ExerciseBehavioural
Flexibility and Balance Exercise Training Exercise 2x weekly for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Resistance Training Exercise | Experimental | 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. Receives: Behavioral: Progressive Resistance Training Exercise |
| Flexibility and Balance Exercise | Active comparator | 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. Receives: Behavioral: Flexibility and Balance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Body composition
Lean body mass measured by dual energy x-ray absorptiometry (DEXA)
Measured: 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.
Measured: 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
Measured: 6 months
Fatigue
Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Dec 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Structured Resistance Exercise vs Control Exercise
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shehzad Basaria, MD, Dana-Farber Cancer Institute
- Investigators
- Shehzad Basaria, MD, Principal investigator, Brigham and Women's HospitalThomas Storer, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485767
- Sponsor's protocol ID
- 20-193
- Other IDs
- R21AG065537
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2020
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing a Decline in Physical Function in Older Androgen-Deprived Men With Structured Exercise Training (RESIST-ADT Trial)
- ClinicalTrials.gov ID
- NCT04485767
- Acronym / sponsor ID
- 20-193
- Conditions
- Prostate Cancer, Physical Function
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy (ADT), Physical Function, Structured Exercise, Muscle Strength and Power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Structured Resistance Exercise vs Control Exercise
| Arm | Type | Receives |
|---|---|---|
| Progressive Resistance Training Exercise | Experimental | Behavioral: Progressive Resistance Training ExerciseMen 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. |
| Flexibility and Balance Exercise | Active comparator | Behavioral: Flexibility and Balance ExerciseMen 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Resistance Training ExerciseProgressive Resistance Training Exercise 2x weekly for 6 months. | Behavioural | Progressive Resistance Training Exercise |
| Flexibility and Balance ExerciseFlexibility and Balance Exercise Training Exercise 2x weekly for 6 months. | Behavioural | Flexibility and Balance Exercise |
Primary outcome
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.
4 secondary outcomes
Body composition
Time frame: 6 months
Muscle strength and power
Time frame: 6 months
Quality of Life (QOL)
Time frame: 6 months
Fatigue
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shehzad Basaria, MD principal investigator
Brigham and Women's Hospital
Thomas Storer, PhD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance Training Exercise and Flexibility and Balance Exercise in people with Prostate Cancer and Physical Function, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loaded stair climb power (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04485767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.