Promoting diet and lifestyle changes for colorectal cancer prevention
Development and Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program
This study is testing whether giving lifestyle and diet advice can help people at higher risk of colorectal cancer stay healthy compared to those who just get regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 1 site (Lyon, Rhone) |
| Trial ID | NCT04257526 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of a lifestyle intervention focused on diet and lifestyle recommendations for individuals at higher risk of colorectal cancer (CRC). Participants, who have a positive faecal immunochemical test but are CRC negative, will be randomly assigned to receive either evidence-based lifestyle advice or usual care. The intervention will be delivered through various materials by health professionals and will assess adherence to dietary recommendations and other health measures over a 12-month period. Data will be collected at multiple time points to evaluate the effectiveness of the intervention on health outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals at high risk for colorectal cancer who have tested positive for adenomas but are CRC negative.
Not a fit: Patients with extensive intestinal surgery, chronic gastrointestinal illnesses, or those on strict diets may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of developing colorectal cancer in high-risk individuals.
How similar studies have performed: Other studies have shown promise in using lifestyle interventions for cancer prevention, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At high risk for CRC but CRC negative (confirmed by colonoscopy) * Able to provide informed consent * Understanding and able to speak French Exclusion Criteria: * Extensive intestinal surgery such as colectomy or surgical resection of the colon * Chronic gastrointestinal illness (inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease) * Use of any systemic antibiotics, antifungals, antivirals, or antiparasitics in the past 3 months * Use of probiotic medications in the past 3 months * Under a strict diet such as meal replacements, diets for co-morbidities such as diabetes * Immobile due to physical constraints (e.g. handicap that is not compatible with physical activities)
Where this trial is running
Lyon, Rhone
- International Agency for Research on Cancer — Lyon, Rhone, France (Recruiting)
Study contacts
- Principal investigator: Marc J Gunter, PhD — International Agency for Research on Cancer
- Study coordinator: Marc J Gunter, PhD
- Email: GunterM@iarc.fr
- Phone: 0033472738093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.