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Health Condition(s) or Problem
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Radiation Enteritis; Radiation Proctitis
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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.
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Who cannot enter the trial
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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.
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What will happen
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Dietary Supplement; FructoOligoSaccharide; A mixture of 70% oligofructose and 30% inulin.; FOS; Dietary Supplement; Maltodextrin; a non-prebiotic carbohydrate; Placebo
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Primary aim
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Gastrointestinal Status
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Secondary Aim
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Short Term Toxicity; 5 weeks or 7.5 weeks; No; To determine the effects of FOS on the short-term toxicity of pelvic irradiation (in comparison to placebo).; See Effects of FOS; 5 or 7.5 weeks, 6 months; No; 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; 5 weeks or 7.5 weeks, 3 months, 6 months; No; 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; 5 weeks or 7.5 weeks, 3 months, 6 months; No; 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.
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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