Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.
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.
1 other identifier
interventional
220
1 country
1
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 weeks in patients with cervical or endometrial carcinoma who are to undergo pelvic radiotherapy with intent to cure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 11, 2011
August 1, 2010
1.8 years
August 10, 2011
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastrointestinal Status
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.
5 weeks or 7.5 weeks
Secondary Outcomes (4)
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
Study Arms (2)
FOS
ACTIVE COMPARATORPrebiotic (FructoOligoSaccharide-FOS.
Placebo
PLACEBO COMPARATORMaltodextrin (non-prebiotic carbohydrate).
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College London Hospital
London, London, NW1 2BU, United Kingdom
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Alastair Forbes, Bsc;MD;FRCP;FHEA
University College London Hospitals/University College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
August 1, 2010
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
August 11, 2011
Record last verified: 2010-08