Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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.

On 22/02/2011 the overall trial end date was changed from 30/06/2010 to 31/07/2012.

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes