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
Completed
- Conditions
- Injury, Occupational Diseases, Poisoning: Radiation injuriesInjury, Occupational Diseases, PoisoningRadiation injuries
- Registration Number
- ISRCTN33398289
- Lead Sponsor
- Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method