Increasing dietary fiber intake during radiation therapy
Dietary Fiber During Radiotherapy and Intestinal Inflammation - a Placebo-controlled Randomized Trial (FIDURA)
This study tests if eating more fiber during radiation therapy can help cancer survivors have better long-term gut health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT04534075 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether increasing dietary fiber intake during radiation therapy can improve long-term intestinal health for cancer survivors. Participants will consume at least 16 g of dietary fiber daily through food and will also take capsules containing either dietary fiber from psyllium husk or a placebo. The study aims to determine if dietary fiber can mitigate adverse effects on intestinal health caused by radiation therapy. Participants will receive guidance through various means, including recipes from chefs and a mobile app to track their fiber intake.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for preoperative or curative radiation therapy for pelvic cavity tumors, such as gynecological, colorectal, anal, prostate, or urinary bladder cancers.
Not a fit: Patients with preoperative stomas, swallowing difficulties, ileus conditions, cognitive dysfunction, or those needing an interpreter for Swedish may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance intestinal health and reduce long-term side effects for cancer survivors undergoing radiation therapy.
How similar studies have performed: While dietary fiber's role during radiation therapy is being explored, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned preoperative (neoadjuvant) or curative radiation therapy for a tumor in the pelvic cavity (including all forms of gynecological cancer, colorectal cancer, anal cancer, prostate cancer, and urinary bladder cancer). Exclusion Criteria: * Preoperative stoma which, according to the attending physician, prevents participation * Difficulty swallowing or ileus conditions which, according to the treating physician, prevent participation * Cognitive dysfunction which, according to the treating physician, prevents participation * Need for an interpreter to communicate in Swedish
Where this trial is running
Gothenburg
- Jubileumskliniken, Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Gunnar N Steineck, MD, PhD — Göteborg University
- Study coordinator: Rebecca Ahlin, M.Sc.
- Email: rebecca.ahlin@vgregion.se
- Phone: +46 76 618 51 30
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.