Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial

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.

Conditions

• Malignant Neoplasm
• Malignant Neoplasm of Rectum
• Malignant Neoplasm of Anus
• Malignant Neoplasm of Urinary Bladder
• Malignant Neoplasm of Cervix
• Malignant Neoplasm of Ovary
• Malignant Neoplasm of Prostate
• Malignant Neoplasm of Large Intestine
• Malignant Neoplasm of Colon
• Gynecologic Cancer

Interventions

BIOLOGICAL

Capsules containing either dietary fiber or placebo

The participants are invited to eat 15 capsules per day. The capsules either contain dietary fiber from psyllium husk or placebo.

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• VGregion

  collaborator UNKNOWN

• Sjöbergstiftelsen

  collaborator UNKNOWN

• Sahlgrenska University Hospital

  lead OTHER

Principal Investigators

• Gunnar N Steineck, MD, PhD · Göteborg University

• Maria Hedelin, PhD · Göteborg University

• Cecilia Bull, PhD · Göteborg University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-02

Primary Completion

2024-09-14

Completion

2024-09-14

Countries

• Sweden

Study Locations