Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01414517
Status:
UNKNOWN
Last Update Posted:
2011-08-11
First Post:
2011-08-10
Brief Title:
Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet
Sponsor:
University College London Hospitals
Organization:
University College London Hospitals
Study Overview
Official Title:
A Double-blind Placebo-controlled Trial of Dietary Supplementation With 15gDay FOS for Five Weeks in Patients With EndometrialCervical Carcinoma or 75 Weeks in Patients With Prostate Carcinoma Undergoing Pelvic Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2010-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will consist of pair of double-blind placebo-controlled trials of dietary supplementation with 15gday FructoOligoSaccharide FOS for 75 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 Description:
The study will consist of pair of double-blind placebo-controlled trials of dietary supplementation with 15gday FructoOligoSaccharide FOS for 75 weeks in patients with prostate carcinoma or 5 weeks in patients with cervicalendometrial 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 endometrialcervical malignancy
The studies are powered to detect the primary outcome measure of a clinical response lower frequency of acute radiation enteritisproctitis at 5 or 75 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 005 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 75 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
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 endometrialcervical malignancy
The studies are powered to detect the primary outcome measure of a clinical response lower frequency of acute radiation enteritisproctitis at 5 or 75 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 005 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 75 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None