Radiation EnteritisPhase 3NCT01414517
Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.
A Phase 3 study testing FructoOligoSaccharide and Maltodextrin in people with Radiation Enteritis and Radiation Proctitis, run by University College London Hospitals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Enteritis, Radiation Proctitis
- What is being tested?
- FructoOligoSaccharide and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, London, NW1 2BU
Adeel Hamad, M.B.B.S, 0845 1555 000 ext. 9011, adeelhamad@msn.com
About this study
Official 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.
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.
Read the 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 weeks in patients with cervical/endometrial 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 endometrial/cervical malignancy.
The studies are powered to detect the primary outcome measure of a clinical response (lower frequency of acute radiation enteritis/proctitis at 5 or 7.5 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 0.05 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 7.5 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.
- Conditions
- Radiation Enteritis, Radiation Proctitis
- Being tested
- FructoOligoSaccharide, Maltodextrin
- Keywords
- Prebiotics, Acute Intestinal Injury, Chronic radiation enteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructoOligoSaccharideDietary supplement
A mixture of 70% oligofructose and 30% inulin.
MaltodextrinDietary supplement
a non-prebiotic carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| FOS | Active comparator | Prebiotic (FructoOligoSaccharide-FOS. Receives: Dietary Supplement: FructoOligoSaccharide |
| Placebo | Placebo comparator | Maltodextrin (non-prebiotic carbohydrate). Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks or 7.5 weeks
Secondary outcomes (4)
Short Term Toxicity
To determine the effects of FOS on the short-term toxicity of pelvic irradiation (in comparison to placebo).
Measured: 5 weeks or 7.5 weeks
See Effects of FOS
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
Measured: 5 or 7.5 weeks, 6 months
Effect of FOS on Chronic Radiation Bowel Disease
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.
Measured: 5 weeks or 7.5 weeks, 3 months, 6 months
Effect on Gut Microbiota
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.
Measured: 5 weeks or 7.5 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EnteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Alastair Forbes, Bsc;MD;FRCP;FHEA, Principal investigator, University College London Hospitals/University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414517
- Sponsor's protocol ID
- 09/H0715/61
- Status last verified
- Aug 2010
- First submitted
- 10 Aug 2011
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01414517
- Acronym / sponsor ID
- 09/H0715/61
- Conditions
- Radiation Enteritis, Radiation Proctitis
- Keywords
- Prebiotics, Acute Intestinal Injury, Chronic radiation enteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 weeks in patients with cervical/endometrial 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 endometrial/cervical malignancy.
The studies are powered to detect the primary outcome measure of a clinical response (lower frequency of acute radiation enteritis/proctitis at 5 or 7.5 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 0.05 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 7.5 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOS | Active comparator | Dietary Supplement: FructoOligoSaccharidePrebiotic (FructoOligoSaccharide-FOS. |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin (non-prebiotic carbohydrate). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FructoOligoSaccharideA mixture of 70% oligofructose and 30% inulin. | Dietary supplement | FOS |
| Maltodextrina non-prebiotic carbohydrate | Dietary supplement | Placebo |
Primary outcome
Gastrointestinal Status
Time frame: 5 weeks or 7.5 weeks
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.
4 secondary outcomes
Short Term Toxicity
Time frame: 5 weeks or 7.5 weeks
See Effects of FOS
Time frame: 5 or 7.5 weeks, 6 months
Effect of FOS on Chronic Radiation Bowel Disease
Time frame: 5 weeks or 7.5 weeks, 3 months, 6 months
Effect on Gut Microbiota
Time frame: 5 weeks or 7.5 weeks, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alastair Forbes, Bsc;MD;FRCP;FHEA principal investigator
University College London Hospitals/University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FructoOligoSaccharide and Maltodextrin in people with Radiation Enteritis and Radiation Proctitis, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alastair Forbes, MD;FRCP;FHEA (0845 1555 000 ext. 9011, a.forbes@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Status (time frame: 5 weeks or 7.5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.