Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33398289
Enrollment
Unknown
Registered
2005-09-30
Start date
2004-03-26
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning: Radiation injuries Injury, Occupational Diseases, Poisoning Radiation injuries

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

Sponsors

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ) 2. Changes in the Vaizey incontinence questionnaire

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026