Clinical trial · Interventional
Step Down Colon Cancer Risk
Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction
NCT01476631CI-TRIAL-00011598terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): not enough patients consented during the funding period
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Walking | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: 30 minutes walking
- description
- First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.
- interventionNames
- Behavioral: Walking
- type
- EXPERIMENTAL
- label
- Arm B: 60 minutes walking
- description
- First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.
- interventionNames
- Behavioral: Walking
Primary outcomes (1)
- measure
- Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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; Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDWolin 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. PMID 22808053