Clinical Trial: Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Double-blind Placebo-controlled Trial of Dietary Supplementation With 15g/Day FOS for Five Weeks in Patients With Endometrial/Cervical Carcinoma or 7.5 Weeks in Patients With Prostate Carcinoma Unde

Brief Summary: The study will consist of pair of double-blind placebo-controlled trials of dietary supplementation with 15g/day FructoOligoSaccharide (FOS) for 7.5 weeks in patients with prostate carcinoma or 5 weeks in patients with cervical or endometrial carcinoma who are to undergo pelvic radiotherapy with intent to cure.

Detailed Summary:

The study will consist of pair of double-blind placebo-controlled trials of dietary supplementation with 15g/day FructoOligoSaccharide (FOS) for 7.5 weeks in patients with prostate carcinoma or 5 weeks in patients with cervical/endometrial carcinoma who are to undergo pelvic radiotherapy with intent to cure. Patients having post-operative adjuvant irradiation will be eligible, but not those having purely palliative treatment for symptom control. The clinical trials will be based at University College Hospital. Patients will attend a screening visit, a baseline visit, and follow-up visits at completion of radiotherapy, and then at three and six months.

Patients will be randomised to take a daily dietary supplement of either placebo (a non-prebiotic carbohydrate) or FOS (a mixture of 70% oligofructose and 30% inulin), provided as a single 15g sachet that can be dissolved in water or added to food. Randomisation in the gynaecological trial will be stratified according to diagnosis. In other respects management will be that offered routinely to patients undergoing pelvic radiotherapy for prostate malignancy or endometrial/cervical malignancy.

The studies are powered to detect the primary outcome measure of a clinical response (lower frequency of acute radiation enteritis/proctitis at 5 or 7.5 weeks respectively) using a 2-sample binomial arcsine where the predicted rate of acute radiation induced bowel disease when on FOS is 50% and 80% on placebo, to a significance of 0.05 and at a power of 90%.

Fifty-one patients will be required in each group to detect a significant difference between FOS and placebo. Therefore 110 patients will be recruited to each of the two studies to allow for attrition.

The primary endpoint will be the c
Sponsor: University College London Hospitals

Current Primary Outcome: Gastrointestinal Status [ Time Frame: 5 weeks or 7.5 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Short Term Toxicity [ Time Frame: 5 weeks or 7.5 weeks ]
  To determine the effects of FOS on the short-term toxicity of pelvic irradiation (in comparison to placebo).
• See Effects of FOS [ Time Frame: 5 or 7.5 weeks, 6 months ]
  To establish the effects of FOS on intestinal integrity, determined endoscopically, biochemically and histologically, after pelvic irradiation, both immediately and at 6 months follow-up
• Effect of FOS on Chronic Radiation Bowel Disease [ Time Frame: 5 weeks or 7.5 weeks, 3 months, 6 months ]
  To provide pilot data to determine whether FOS given during pelvic irradiation has an effect on the risk of clinically apparent chronic radiation bowel disease.
• Effect on Gut Microbiota [ Time Frame: 5 weeks or 7.5 weeks, 3 months, 6 months ]
  To confirm using fluorescence in-situ hybridization (FISH) the changes in the gut microbiota in patients on FOS enhanced diet in comparison with standard diet.

Original Secondary Outcome: Same as current

Information By: University College London Hospitals

Dates:
Date Received: August 10, 2011
Date Started: August 2010
Date Completion: August 2012
Last Updated: August 10, 2011
Last Verified: August 2010