Status:
UNKNOWN
Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.
Lead Sponsor:
University College London Hospitals
Conditions:
Radiation Enteritis
Radiation Proctitis
Eligibility:
All Genders
Phase:
PHASE3
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 week...
Detailed Description
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 week...
Eligibility Criteria
Inclusion
- The study group will comprise men and women aged 18 years or older with a histologically proven diagnosis of carcinoma of the prostate or carcinoma of the cervix or endometrium in whom radical radiotherapy has been selected in their treatment plan following assessment by the prostate oncology or gynecological oncology multidisciplinary team
Exclusion
- Exclusion criteria will preclude the recruitment of those having radiotherapy for purely palliative reasons. Patients known to have a current infection with an enteric pathogen, or who have used antibiotics within the past month, consumed any probiotic or prebiotic within the last month, or used any rectal/topical therapy within the last month will also be ineligible. Those known or suspected to have inflammatory bowel disease (ulcerative colitis or Crohn's disease) will be ineligible. Patients requiring hospitalisation, and those considered by the chief investigator (CI) to have important hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease will also be ineligible.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01414517
Start Date
August 1 2010
End Date
August 1 2012
Last Update
August 11 2011
Active Locations (1)
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1
University College London Hospital
London, London, United Kingdom, NW1 2BU