| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN33398289 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0258134912 |
| Public title | A 2 x 2 randomised, double blind, placebo controlled trial of pentoxifylline (trental) +/- high dose vitamins for radiation induced bowel toxicity: the ROBOTS 2 trial |
| Scientific title |
|
| Acronym | ROBOTS 2 (Relief Of BOwel Toxicity Study 2) |
| Disease/condition/study domain | Injury, Occupational Diseases, Poisoning: Radiation injuries |
| Study hypothesis | This would be the first randomised trial addressing this issue in patients with bowel symptoms after radiotherapy. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients referred at least three months after pelvic radiotherapy
2. Patients must have gastrointestinal symptoms which were not present before radiotherapy
3. Must have undergone adequate gastroenterological assessment to reach a diagnosis
4. Must have residual gastrointestinal symptoms after three months of best therapy |
| Participants - exclusion criteria | 1. Previous cerebrovascular haemorrhage
2. Previous retinal haemorrhage
3. Liver cirrhosis
4. Symptomatic coronary artery disease
5. Abnormal renal function and creatine clearance
6. History of renal tract stone
7. Evidence of recurrent disease |
| Patient information material |
|
| Anticipated start date | 26/03/2004 |
| Anticipated end date | 13/04/2008 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients will be randomised in a 2 x 2 factorial fashion to:
1. Pentoxifylline (trental)
2. High dose vitamins
3. Pentoxifylline (trental) with high dose vitamins
4. Placebo |
| Primary outcome measure(s) | 1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ)
2. Changes in the Vaizey incontinence questionnaire |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | 1. The Royal Marsden NHS Foundation Trust (UK)
2. NHS R&D Support Funding (UK) |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Jervoise Andreyev |
| Contact details | Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton, Surrey
United Kingdom
SM2 5PT |
| Contact telephone | +44 (0)20 8643 8901 |
| Contact fax | +44 (0)20 7808 2048 |
| Contact email | j.andreyev@imperial.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN33398289 |
| Date last extracted from ISRCTN register | 17/04/2008 |
