Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.

NCT ID: NCT01414517

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

FOS

Prebiotic (FructoOligoSaccharide-FOS.

Group Type: ACTIVE_COMPARATOR

FructoOligoSaccharide

Intervention Type: DIETARY_SUPPLEMENT

A mixture of 70% oligofructose and 30% inulin.

Placebo

Maltodextrin (non-prebiotic carbohydrate).

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

a non-prebiotic carbohydrate

Interventions

FructoOligoSaccharide

A mixture of 70% oligofructose and 30% inulin.

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

a non-prebiotic carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College London Hospitals

OTHER

Sponsor Role: lead

Responsible Party

University College London Hospitals NHS Foundation Trust

Principal Investigators

Alastair Forbes, Bsc;MD;FRCP;FHEA

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals/University College London

Locations

University College London Hospital

London, London, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Alastair Forbes, MD;FRCP;FHEA

Role: CONTACT

a.forbes@ucl.ac.uk

0845 1555 000 ext. 9011

Facility Contacts

Adeel Hamad, M.B.B.S

Role: primary

adeelhamad@msn.com

0845 1555 000 ext. 9011

Other Identifiers

09/H0715/61

Identifier Type: -

Identifier Source: org_study_id