Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet. | Recruiting
Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.
Health Conditions
  • Radiation Enteritis
  • Radiation Proctitis
Recruiting
Recruitment Status
NCT01414517
Primary Trial ID Number
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.
Primary Outcome Measures
  • Gastrointestinal Status; 5 weeks or 7.5 weeks
Secondary Outcome Measures
  • Short Term Toxicity; 5 weeks or 7.5 weeks; See Effects of FOS; 5 or 7.5 weeks, 6 months; Effect of FOS on Chronic Radiation Bowel Disease; 5 weeks or 7.5 weeks, 3 months, 6 months; Effect on Gut Microbiota; 5 weeks or 7.5 weeks, 3 months, 6 months
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
N/A to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
220
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - 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 Criteria:
  • - 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.
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - 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 Criteria:
  • - 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.
Interventions
Dietary Supplement; FructoOligoSaccharide; A mixture of 70% oligofructose and 30% inulin.; [FOS]; Dietary Supplement; Maltodextrin; a non-prebiotic carbohydrate; [Placebo]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Results Reporting
Sorry, this information is not available
Acronym
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Scientific 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.
Secondary Trial Identifying Number
Sorry, this information is not available
Website
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Study Funded By
University College London Hospitals
Funder Type
Sorry, this information is not available
Study Sponsored By
University College London Hospitals
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

10 Aug 2011

Last Updated

10 Aug 2011

Date Record Refreshed on UKCTG

31 Jul 2015