Prostate CancerPACMenNCT03331458
Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
A study testing exrecise intervention in people with Prostate Cancer, run by Duke University at 1 site in United States.
Trial summary
Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- exrecise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 21 Mar 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with prostate cancer
- will not start treatment for at least 2 weeks
- able to read and understand English
- capable of giving informed consent
- at least 18 years old
Who cannot join
- patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
- unable to provide informed consent as assessed by the interviewer
- too sick to participate, as judged by a member of the research team or the exercise physiologist
- have been treated for another cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Raleigh Cancer Center
Raleigh, North Carolina, 27606
About this study
Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.
The purpose of this study is to
- Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
- Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:
- Examine intervention safety and tolerance by self-report
- Examine changes in functional capacity by 6-minute walk test
- Examine changes in symptom experience by self-report
- Conditions
- Prostate Cancer
- Being tested
- exrecise intervention
- Keywords
- physical activity
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exrecise interventionBehavioural
Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures
| Study group | Role | What they receive |
|---|---|---|
| subjects with prostate cancer | Experimental | Not described Receives: Behavioral: exrecise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk test
Distance walked in 6 minutes
Measured: baseline, 2 weeks post intervention
Change in balance test
Ability to balance
Measured: baseline, 2 weeks post intervention
Change in time up to go test
Time to get up from chair, walk 30 meters and return to sit in chair
Measured: baseline, 2 weeks post intervention
Change in Godin Leisure Time Score
physical activity score
Measured: baseline, 2 weeks post intervention
Change in rate of perceived exertion
physical exertion score
Measured: baseline, 2 weeks post intervention
Change in metabolic equivalent
metabolic activity score
Measured: baseline, 2 weeks post intervention
Change in distress score
distress score
Measured: baseline, 2 weeks post intervention
Change in self-efficacy score
self-efficacy score
Measured: baseline, 2 weeks post intervention
Change in symptom inventory score
description of symptoms
Measured: baseline, 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start17 Apr 2018
- Primary completion21 Mar 2019
- Study completion21 Mar 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 Duke UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Allen, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331458
- Sponsor's protocol ID
- Pro00083320
- Acronym
- PACMen
- Status last verified
- Aug 2019
- First submitted
- 1 Nov 2017
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share feasibility study data
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03331458
- Acronym / sponsor ID
- PACMen / Pro00083320
- Conditions
- Prostate Cancer
- Keywords
- physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 6 Nov 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.
Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.
The purpose of this study is to
- Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and
- Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:
- Examine intervention safety and tolerance by self-report
- Examine changes in functional capacity by 6-minute walk test
- Examine changes in symptom experience by self-report
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with prostate cancer | Experimental | Behavioral: exrecise intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed with prostate cancer
- will not start treatment for at least 2 weeks
- able to read and understand English
- capable of giving informed consent
- at least 18 years old
Key exclusion criteria (4 listed)
- patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
- unable to provide informed consent as assessed by the interviewer
- too sick to participate, as judged by a member of the research team or the exercise physiologist
- have been treated for another cancer
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 |
|---|---|---|
| exrecise interventionSubjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures | Behavioural | subjects with prostate cancer |
Primary outcome
Change in 6 minute walk test
Time frame: baseline, 2 weeks post intervention
Distance walked in 6 minutes
Change in balance test
Time frame: baseline, 2 weeks post intervention
Ability to balance
Change in time up to go test
Time frame: baseline, 2 weeks post intervention
Time to get up from chair, walk 30 meters and return to sit in chair
Change in Godin Leisure Time Score
Time frame: baseline, 2 weeks post intervention
physical activity score
Change in rate of perceived exertion
Time frame: baseline, 2 weeks post intervention
physical exertion score
Change in metabolic equivalent
Time frame: baseline, 2 weeks post intervention
metabolic activity score
Change in distress score
Time frame: baseline, 2 weeks post intervention
distress score
Change in self-efficacy score
Time frame: baseline, 2 weeks post intervention
self-efficacy score
Change in symptom inventory score
Time frame: baseline, 2 weeks post intervention
description of symptoms
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 26 Aug 2019.
- Individual participant dataSharing planned: No. No plan to share feasibility study data
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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.
Deborah Allen principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exrecise intervention in people with Prostate Cancer, run by Duke University 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 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 26 Aug 2019. 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 in 6 minute walk test (time frame: baseline, 2 weeks post intervention). The study lists 9 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 26 Aug 2019.