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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN33398289 |
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Date of registration:
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30/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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26/03/2004 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN33398289 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Jervoise
Andreyev |
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Address:
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Medicine Section
Royal Marsden NHS Trust
Downs Road
SM2 5PT
Sutton, Surrey
United Kingdom |
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Telephone:
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+44 (0)20 8643 8901 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Injury, Occupational Diseases, Poisoning: Radiation injuries
Injury, Occupational Diseases, Poisoning
Radiation injuries
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Intervention(s)
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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(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(s)
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Not provided at time of registration
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Secondary ID(s)
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N0258134912
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Source(s) of Monetary Support
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The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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