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
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

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

Phone +44 (0)20 8643 8901

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymROBOTS 2 (Relief Of BOwel Toxicity Study 2)
Study objectivesThis 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) studiedInjury, Occupational Diseases, Poisoning: Radiation injuries
InterventionPatients 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 typeSupplement
Primary outcome measure1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ)
2. Changes in the Vaizey incontinence questionnaire
Secondary outcome measuresNot provided at time of registration
Overall study start date26/03/2004
Completion date13/04/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteria1. 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 enrolment26/03/2004
Date of final enrolment13/04/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan