The effective management of radiation-induced bowel injury: a randomised controlled trial

ISRCTN	ISRCTN22890916
DOI	https://doi.org/10.1186/ISRCTN22890916
Secondary identifying numbers	N0258191022

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 29/03/2022

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

http://www.cancerhelp.org.uk/trials/a-study-to-improve-treatment-for-side-effects-of-radiotherapy-to-the-bowel

Contact information

Dr Jervoise Andreyev
Scientific

Gastrointestinal Unit, Department of Medicine
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Phone	+44 020 7808 2105
Email	j@andreyev.demon.co.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The effective management of radiation-induced bowel injury: a randomised controlled trial
Study objectives	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(s)	The Royal Marsden Research Ethics Committee (now merged with South West London REC1), 26/03/2007, ref: 07/Q0801/47
Health condition(s) or problem(s) studied	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
Primary outcome measure	Improvement in gastrointestinal symptoms
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2007
Completion date	31/07/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	250 RMH participants
Total final enrolment	218
Key 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
Key exclusion criteria	Added May 2008: 1. Patient refusing to give informed consent 2. Patients deemed by their clinical oncologist to require immediate gastroenterological assessment
Date of first enrolment	26/11/2007
Date of final enrolment	12/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Marsden NHS Trust

London
SW3 6JJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, 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

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results		23/07/2018	29/03/2022	No	Yes

Editorial Notes

29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
22/02/2011: The overall trial end date was changed from 30/06/2010 to 31/07/2012.