NCT04534075CompletedPhase 3
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial
Dietary Fiber During Radiotherapy and Intestinal Inflammation - a Placebo-controlled Randomized Trial (FIDURA)
Source: ClinicalTrials.gov · Last updated 8 Sept 2025
Brief summary (registry, in English)
The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 354 (actual)
- First submitted
- 22 Aug 2020
- Start date
- 2 Sept 2020
- Primary completion date
- 14 Sept 2024
- Lead sponsor
- Sahlgrenska University Hospital
- NCT number
- NCT04534075
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 354
- From 2 Sept 2020 to the primary completion date, 14 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Difficulty swallowing or ileus conditions which, according to the treating physician, prevent participation
Other
- Preoperative stoma which, according to the attending physician, prevents participation
- Cognitive dysfunction which, according to the treating physician, prevents participation
- Need for an interpreter to communicate in Swedish
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jubileumskliniken, Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.