Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.
|ClinicalTrials.gov Identifier: NCT01414517|
Recruitment Status : Unknown
Verified August 2010 by University College London Hospitals.
Recruitment status was: Recruiting
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Radiation Enteritis Radiation Proctitis||Dietary Supplement: FructoOligoSaccharide Dietary Supplement: Maltodextrin||Phase 3|
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 clinical gastrointestinal status at 7.5 weeks or 5 weeks at completion of radiotherapy. This status will be enumerated in comparison with placebo treated patients from the Birmingham score of intestinal symptoms (a simple clinical score from 0-15, usually employed in ulcerative colitis). Most patients commencing radiotherapy for these malignancies will have a pre-treatment score of zero or 1. A score of 4 or more is indicative of active coloproctitis, and differences of more than 2 points are to be considered clinically meaningful.
Secondary clinical endpoints will include the quantity of anti-diarrhoeal medication required, the international harmonised criteria for radiation toxicity, the EuroQol score of quality of life, and the appearance of the rectal mucosa: as judged endoscopically using the Baron score (a 0-3 scale usually employed in ulcerative colitis); and semi-quantitatively from histological assessment.
The Birmingham score and each of the clinical secondary endpoints will be assessed again at 3 and 6 months after completion of the radiotherapy. Endoscopic and histological assessment will be repeated only at 6 months after completion of radiotherapy.
Laboratory endpoints will include the measurement of short chain fatty acids (SCFA) (including butyrate) in faeces at baseline and at completion of radiotherapy, and study of the microbiota profile in the mucosa as determined by fluorescence in-situ hybridization (FISH). Haematological and biochemical parameters will be monitored as in standard practice.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Undergoing Pelvic Radiotherapy.|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||August 2012|
Active Comparator: FOS
Dietary Supplement: FructoOligoSaccharide
A mixture of 70% oligofructose and 30% inulin.
Placebo Comparator: Placebo
Maltodextrin (non-prebiotic carbohydrate).
Dietary Supplement: Maltodextrin
a non-prebiotic carbohydrate
- Gastrointestinal Status [ Time Frame: 5 weeks or 7.5 weeks ]To determine whether there is a difference in gastrointestinal status at 5 weeks (enumerated through the Birmingham score) in patients undergoing pelvic irradiation for gynaecological malignancy or at 7.5 weeks in patients undergoing radiotherapy for prostate malignancy given a prebiotic enhanced diet and those on placebo.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414517
|Contact: Alastair Forbes, MD;FRCP;FHEA||0845 1555 000 ext firstname.lastname@example.org|
|University College London Hospital||Recruiting|
|London, United Kingdom, NW1 2BU|
|Contact: Adeel Hamad, M.B.B.S 0845 1555 000 ext 9011 email@example.com|
|Principal Investigator:||Alastair Forbes, Bsc;MD;FRCP;FHEA||University College London Hospitals/University College London|