Adenomatous PolypsNCT01476631
Step Down Colon Cancer Risk
A study testing Walking in people with Adenomatous Polyps, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Hypothesis 1: Exercise will decrease serum markers in a dose response manner. Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2010
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 50 to 80
- no personal cancer history
- found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months
- no contraindications to beginning an exercise program
- no previous diagnosis of familial polyposis syndromes
- no previous diagnosis of ulcerative colitis or Crohn's disease;
Who cannot join
- Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction
Hypothesis 1: Exercise will decrease serum markers in a dose response manner.
Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.
Read the detailed description
Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2.
Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.
- Conditions
- Adenomatous Polyps
- Being tested
- Walking
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
- 7 days prior to baseline participants must wear a blinded pedometer
- At baseline information on the blinded pedometer will downloaded to the computer for analysis as well as number of days worn and hours of wear. Sociodemographic, cancer risk factors, height/weight, fast blood draw to check levels on insulin, C-peptide, IL-6 and PEG-2 and questionnaires PPAQ, Exercise Confident Survey and Sallis Social Support Scale, Day/night; Home/Work, neighborhood safety, HINTS, IPAPS, CES-D, Brief COPE, Urban and Life Stress Scale.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: 30 minutes walking | Experimental | First Step program with 30 minutes of walking and 10,000 steps per day for 3 months. Receives: Behavioral: Walking |
| Arm B: 60 minutes walking | Experimental | First Step program with 60 minutes of walking and 13,000 steps per day for 3 months. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.
Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels.
Measured: 3 months
Secondary outcomes (1)
Participants in the 60 minute intervention will have significantly higher physical activity levels (measured by pedometer and accelerometer) than those in the 30 minute intervention at three months.
Comparing changes in the secondary outcome of physical activity over three months, as measured by pedometer and accelerometer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: not enough patients consented during the funding period
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 Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Y. Wolin, ScD, FACSM, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476631
- Sponsor's protocol ID
- 201105308
- Status last verified
- Aug 2013
- First submitted
- 9 Nov 2011
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolin KY, Fagin C, James AS, Early DS. Promoting physical activity in patients with colon adenomas: a randomized pilot intervention trial. PLoS One. 2012;7(7):e39719. doi: 10.1371/journal.pone.0039719. Epub 2012 Jul 13.
PubMed 22808053
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction
- ClinicalTrials.gov ID
- NCT01476631
- Acronym / sponsor ID
- 201105308
- Conditions
- Adenomatous Polyps
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients consented during the funding period
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
Hypothesis 1: Exercise will decrease serum markers in a dose response manner.
Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.
Detailed description
Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2.
Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: 30 minutes walking | Experimental | Behavioral: WalkingFirst Step program with 30 minutes of walking and 10,000 steps per day for 3 months. |
| Arm B: 60 minutes walking | Experimental | Behavioral: WalkingFirst Step program with 60 minutes of walking and 13,000 steps per day for 3 months. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 50 to 80
- no personal cancer history
- found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months
- no contraindications to beginning an exercise program
- no previous diagnosis of familial polyposis syndromes
Key exclusion criteria (1 listed)
- Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.
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 |
|---|---|---|
| Walking* 7 days prior to baseline participants must wear a blinded pedometer * At baseline information on the blinded pedometer will downloaded to the computer for analysis as well as number of days worn and hours of wear. Sociodemographic, cancer risk factors, height/weight, fast blood draw to check levels on insulin, C-peptide, IL-6 and PEG-2 and questionnaires PPAQ, Exercise Confident Survey and Sallis Social Support Scale, Day/night; Home/Work, neighborhood safety, HINTS, IPAPS, CES-D, Brief COPE, Urban and Life Stress Scale. | Behavioural | Arm A: 30 minutes walking, Arm B: 60 minutes walking |
Primary outcome
Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.
Time frame: 3 months
Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels.
1 secondary outcome
Participants in the 60 minute intervention will have significantly higher physical activity levels (measured by pedometer and accelerometer) than those in the 30 minute intervention at three months.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: not enough patients consented during the funding period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
- Derived from this study: PubMed 22808053Wolin KY, Fagin C, James AS, Early DS. Promoting physical activity in patients with colon adenomas: a randomized pilot intervention trial. PLoS One. 2012;7(7):e39719. doi: 10.1371/journal.pone.0039719. Epub 2012 Jul 13.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Kathleen Y. Wolin, ScD, FACSM principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking in people with Adenomatous Polyps, run by Washington University School of Medicine 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Aug 2013. 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 was stopped early (reason given: not enough patients consented during the funding period). Results are not available in the source record.
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?
Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner. (time frame: 3 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 NCT01476631, 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 5 Aug 2013.