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
DOI	https://doi.org/10.1186/ISRCTN33398289
Protocol serial number	N0258134912
Sponsor	Department of Health
Funders	The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding (UK)

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

Dr Jervoise Andreyev
Scientific

Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom

Phone	+44 (0)20 8643 8901

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ) 2. Changes in the Vaizey incontinence questionnaire
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	13/04/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

Medicine Section

Sutton, Surrey
SM2 5PT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan