Prostate CancerNCT03070145
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy
A study testing Exercise Intervention in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2017to 12 Dec 2019
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to any study-related procedures
- History of histologically confirmed prostate cancer
- Initiating or within 30 days of initiating ADT
- ECOG performance status of 0 or 1
- At least 18 years old and no older than 80 years
- Physically able to exercise and have physician consent from their treating physician to start a physical activity program
Show all 10Show fewer
- English speaking and able to read English
- Have access to and are able to use the internet at a minimum of once per week
- Sufficient proficiency and confidence to use the internet and follow video-based instructions, as determined by the eligibility questionnaire to be completed by the participant
- Willingness to be randomized
Who cannot join
- Self-reported inability to walk 2 blocks (at any pace)
- Currently physically active (> 90 minutes of moderate or vigorous physical activity per week) as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire [LSI])
- Previously on ADT
- Radiologic evidence of distant disease
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
- Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer
Read the detailed description
Androgen deprivation therapy (ADT) is a key treatment of prostate cancer. While this therapy improves prostate cancer outcomes, ADT also has a variety of short- and long-term adverse effects, including increased body weight, loss of lean muscle mass, reductions in quality of life, and increased risk of cardiovascular disease. Studies have shown that among men with prostate cancer, physical activity is associated with improved outcomes, including a reduced risk of mortality, from prostate cancer and other causes. Our hypothesis is that physical activity will improve some of the physical and emotional side effects associated with ADT. Physical activity, such as brisk walking and moderate strength training, offers a lifestyle factor that may improve some of the side effects, and is low-cost and easy to do.
The investigators are conducting this study to evaluate the impact and feasibility of a 12-week moderate-intensity aerobic and strength training exercise intervention, including a virtual component. The intervention includes brisk walking and moderate strength training, and involves home-based exercises, in-person sessions with an oncology-trained exercise physiologist, optional group training sessions, and weekly training goals. Participants will have access to a personalized web-based platform called Postwire, which will include videos of training sessions, and will allow participants to easily communicate with the study staff and with other study participants.
- Conditions
- Prostate Cancer
- Being tested
- Exercise Intervention
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week moderate-intensity aerobic and strength training exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | * 12-weeks brisk walking and strength training
* 150 minute moderate aerobic activities, such as brisk walking
* Strength training 3 days /week
* One on one sessions with exercise physiologist
* Optional group sessions Receives: Other: Exercise Intervention |
| Usual Care | No intervention | Usual Care provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Physical Performance at 12 weeks
The 6 Minute Walk Test will be performed at the clinic, where the participants will wear tennis shoes and will walk indoors on a flat surface for 6 minutes.
Measured: Baseline and 12 weeks
Change from Baseline in Physiologic Measurements at 12 weeks
Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant.
Measured: Baseline and 12 weeks
Change from Baseline in Blood Pressure at 12 weeks
The investigators will obtain participant's blood pressure from the most recent clinical visit.
Measured: Baseline and 12 weeks
Change from Baseline in Body Composition at 12 weeks
Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.
Measured: Baseline and 12 weeks
Secondary outcomes (13)
Fatigue
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function.
Measured: Baseline and 12 weeks
Physical Functioning
The investigators will assess changes in physical functioning from study enrollment to the completion of the study period using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3) and the Prostate Cancer Specific EORTC questionnaire.
Measured: Baseline and 12 weeks
Minutes of Physical Activity
The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR)
Measured: Baseline and 12 weeks
Anthropometric Measures
The investigators will assess changes in height from baseline to 12 weeks using a tape measure.
Measured: Baseline and 12 weeks
Anthropometric Measures
The investigators will assess changes in weight from baseline to 12 weeks using a scale.
Measured: Baseline and 12 weeks
Anthropometric Measures
The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure.
Measured: Baseline and 12 weeks.
Biomarkers
The investigators will assess PSA at baseline and 12-weeks in both the usual care and intervention arm.
Measured: Baseline and 12 weeks.
Biomarkers
The investigators will assess testosterone levels at baseline and 12-weeks in both the usual care and intervention arm.
Measured: Baseline and 12 weeks.
Measure adherence
The investigators will evaluate adherence rates to study procedures by using self-report and FitBit
Measured: Baseline and 12 weeks
Measure feasibility
Feasibility measured by number of eligible members of the targeted population
Measured: Baseline and 12 weeks
Measure feasibility
Feasibility measured by recruitment rates
Measured: Baseline and 12 weeks
Measure feasibility
Feasibility measured by refusal rates for participation and randomization
Measured: Baseline and 12 weeks
Measure feasibility
Feasibility measured by level of engagement with Postwire and with other study participants.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start8 Dec 2017
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Nguyen, MD, Dana-Farber Cancer Institute
- Investigators
- Paul L. Nguyen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070145
- Sponsor's protocol ID
- 16-515
- Status last verified
- Sep 2021
- First submitted
- 6 Feb 2017
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT03070145
- Acronym / sponsor ID
- 16-515
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 3 Mar 2017 (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.
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer
Detailed description
Androgen deprivation therapy (ADT) is a key treatment of prostate cancer. While this therapy improves prostate cancer outcomes, ADT also has a variety of short- and long-term adverse effects, including increased body weight, loss of lean muscle mass, reductions in quality of life, and increased risk of cardiovascular disease. Studies have shown that among men with prostate cancer, physical activity is associated with improved outcomes, including a reduced risk of mortality, from prostate cancer and other causes. Our hypothesis is that physical activity will improve some of the physical and emotional side effects associated with ADT. Physical activity, such as brisk walking and moderate strength training, offers a lifestyle factor that may improve some of the side effects, and is low-cost and easy to do.
The investigators are conducting this study to evaluate the impact and feasibility of a 12-week moderate-intensity aerobic and strength training exercise intervention, including a virtual component. The intervention includes brisk walking and moderate strength training, and involves home-based exercises, in-person sessions with an oncology-trained exercise physiologist, optional group training sessions, and weekly training goals. Participants will have access to a personalized web-based platform called Postwire, which will include videos of training sessions, and will allow participants to easily communicate with the study staff and with other study participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Exercise Intervention* 12-weeks brisk walking and strength training * 150 minute moderate aerobic activities, such as brisk walking * Strength training 3 days /week * One on one sessions with exercise physiologist * Optional group sessions |
| Usual Care | No intervention | –Usual Care provided |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent prior to any study-related procedures
- History of histologically confirmed prostate cancer
- Initiating or within 30 days of initiating ADT
- ECOG performance status of 0 or 1
- At least 18 years old and no older than 80 years
Key exclusion criteria (6 listed)
- Self-reported inability to walk 2 blocks (at any pace)
- Currently physically active (> 90 minutes of moderate or vigorous physical activity per week) as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire [LSI])
- Previously on ADT
- Radiologic evidence of distant disease
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
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 |
|---|---|---|
| Exercise Intervention12-week moderate-intensity aerobic and strength training exercise intervention | Other | Exercise Intervention |
Primary outcome
Change from Baseline in Physical Performance at 12 weeks
Time frame: Baseline and 12 weeks
The 6 Minute Walk Test will be performed at the clinic, where the participants will wear tennis shoes and will walk indoors on a flat surface for 6 minutes.
Change from Baseline in Physiologic Measurements at 12 weeks
Time frame: Baseline and 12 weeks
Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant.
Change from Baseline in Blood Pressure at 12 weeks
Time frame: Baseline and 12 weeks
The investigators will obtain participant's blood pressure from the most recent clinical visit.
Change from Baseline in Body Composition at 12 weeks
Time frame: Baseline and 12 weeks
Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.
13 secondary outcomes
Fatigue
Time frame: Baseline and 12 weeks
Physical Functioning
Time frame: Baseline and 12 weeks
Minutes of Physical Activity
Time frame: Baseline and 12 weeks
Anthropometric Measures
Time frame: Baseline and 12 weeks
Anthropometric Measures
Time frame: Baseline and 12 weeks
Anthropometric Measures
Time frame: Baseline and 12 weeks.
Biomarkers
Time frame: Baseline and 12 weeks.
Biomarkers
Time frame: Baseline and 12 weeks.
Measure adherence
Time frame: Baseline and 12 weeks
Measure feasibility
Time frame: Baseline and 12 weeks
Measure feasibility
Time frame: Baseline and 12 weeks
Measure feasibility
Time frame: Baseline and 12 weeks
Measure feasibility
Time frame: Baseline and 12 weeks
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 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Paul L. Nguyen, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site 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 10 inclusion and 6 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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from Baseline in Physical Performance at 12 weeks (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2021.