Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258134912
Study information
Scientific title
Acronym
ROBOTS 2 (Relief Of BOwel Toxicity Study 2)
Study hypothesis
This would be the first randomised trial addressing this issue in patients with bowel symptoms after radiotherapy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Pentoxifylline (trental), high dose vitamins
Primary outcome measures
1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ)
2. Changes in the Vaizey incontinence questionnaire
Secondary outcome measures
Not provided at time of registration
Overall trial start date
26/03/2004
Overall trial end date
13/04/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
26/03/2004
Recruitment end date
13/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary