Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jervoise Andreyev
ORCID ID
Contact details
Gastrointestinal Unit
Department of Medicine
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom
+44 020 7808 2105
j@andreyev.demon.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258191022
Study information
Scientific title
The effective management of radiation-induced bowel injury: a randomised controlled trial
Acronym
Study hypothesis
To assess which tests can help decide the cause of these patients symptoms' whether treatments in fact improve patients' quality of life and whether these treatments can be delivered usefully by a specialist nurse.
Ethics approval
The Royal Marsden Research Ethics Committee (now merged with South West London REC1), 26/03/2007, ref: 07/Q0801/47
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Radiation
Intervention
Randomised test intervention vs standardised intervention, non-blinded (Phase III).
Observational (no treatment or diagnostic intervention), Quality of Life Assessment, Qualitative Study
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Improvement in gastrointestinal symptoms
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2007
Overall trial end date
31/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who have a life expectancy of more than 1 year and who have received radical pelvic radiotherapy with curative intent six months previously and who subsequently have developed new onset troublesome gastrointestinal symptoms
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
250 RMH participants
Participant exclusion criteria
Added May 2008:
1. Patient refusing to give informed consent
2. Patients deemed by their clinical oncologist to require immediate gastroenterological assessment
Recruitment start date
26/11/2007
Recruitment end date
12/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden NHS Trust
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)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
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
Basic results (scientific)
Publication list