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
ISRCTN | ISRCTN33398289 |
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DOI | https://doi.org/10.1186/ISRCTN33398289 |
Secondary identifying numbers | N0258134912 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jervoise Andreyev
Scientific
Scientific
Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom
Phone | +44 (0)20 8643 8901 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | ROBOTS 2 (Relief Of BOwel Toxicity Study 2) |
Study objectives | This would be the first randomised trial addressing this issue in patients with bowel symptoms after radiotherapy. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Radiation injuries |
Intervention | 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 |
Intervention type | Supplement |
Primary outcome measure | 1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ) 2. Changes in the Vaizey incontinence questionnaire |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 26/03/2004 |
Completion date | 13/04/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key 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 |
Key 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 |
Date of first enrolment | 26/03/2004 |
Date of final enrolment | 13/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Royal Marsden NHS Foundation Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |