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Search / Trial NCT04534075

Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial

Launched by SAHLGRENSKA UNIVERSITY HOSPITAL · Aug 26, 2020

Trial Information

Current as of August 31, 2025

Recruiting

Keywords

Radiotherapy Irradiation Radiation Therapy Dietary Fiber Psyllium Husk Placebo Controlled Double Blind Randomized Patient Reported Outcomes E Proms Gut Wall Inflammation Late Adverse Effects Late Effects Treatment Induced Cancer Survivorship Diseases Treatment Induced Cancer Survivorship Syndromes Intestinal Health Bowel Health Urgency Leakage Mucus Flatulence Blood Discharge

ClinConnect Summary

This clinical trial is studying whether increasing dietary fiber intake during radiation therapy can help improve long-term digestive health for cancer survivors. The researchers believe that eating more fiber might have positive effects, but they also want to see if it causes any short-term side effects. Participants in the study will need to eat at least 16 grams of fiber each day from food and may also take capsules that provide an additional 5.5 grams of fiber or a placebo (a capsule with no active ingredient).

To participate, individuals should be planning to undergo radiation therapy for certain types of pelvic cancers, including cancers of the rectum, anus, bladder, cervix, ovary, prostate, and colon. However, those with certain conditions, such as swallowing difficulties or cognitive issues, may not be eligible. If you join the trial, you can expect guidance on how to increase your fiber intake and regular check-ins to see how you're doing during treatment. This trial is currently looking for participants, and both men and women between the ages of 65 and 74 years are welcome to take part.

Gender

ALL

Eligibility 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

About Sahlgrenska University Hospital

Sahlgrenska University Hospital, a leading healthcare institution in Sweden, is at the forefront of clinical research and innovation. Affiliated with the University of Gothenburg, the hospital integrates advanced medical care with cutting-edge research, facilitating a collaborative environment for scientific exploration and clinical trials. With a commitment to improving patient outcomes, Sahlgrenska University Hospital focuses on a wide range of therapeutic areas, leveraging its multidisciplinary expertise to advance healthcare solutions. The institution is dedicated to fostering ethical research practices and ensuring the highest standards of patient safety and care in all clinical trials.

Locations

Gothenburg, , Sweden

Patients applied

0 patients applied

Trial Officials

Gunnar N Steineck, MD, PhD

Principal Investigator

Göteborg University

Maria Hedelin, PhD

Study Chair

Göteborg University

Cecilia Bull, PhD

Study Chair

Göteborg University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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