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ISRCTN
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ISRCTN33398289
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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ROBOTS 2 (Relief Of BOwel Toxicity Study 2)
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Serial number at source
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N0258134912
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Study hypothesis
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This would be the first randomised trial addressing this issue in patients with bowel symptoms after radiotherapy.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Injury, Occupational Diseases, Poisoning: Radiation injuries
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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26/03/2004
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Anticipated end date
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13/04/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ)
2. Changes in the Vaizey incontinence questionnaire
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. The Royal Marsden NHS Foundation Trust (UK)
2. NHS R&D Support Funding (UK)
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Trial website
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Publications
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Contact name
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Dr
Jervoise
Andreyev
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Address
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Medicine Section
Royal Marsden NHS Trust
Downs Road
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City/town
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Sutton, Surrey
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Tel
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+44 (0)20 8643 8901
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Fax
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+44 (0)20 7808 2048
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Email
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j.andreyev@imperial.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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14/04/2008
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Date ISRCTN assigned
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30/09/2005
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