CompletedPhase 3

Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial

Sweden354 participantsStarted 2020-09-02

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sign of inflammation i blood

Timeframe: One month after the end of radiotherapy

Intensity of the urgency syndrome

Timeframe: One year after the end of radiotherapy

Trial details

NCT IDNCT04534075

SponsorSahlgrenska University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-14

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