The clinical benefit and cost effectiveness of a gastrointestinal care bundle for patients undergoing pelvic chemoradiotherapy

ISRCTN	ISRCTN78348850
DOI	https://doi.org/10.1186/ISRCTN78348850
Secondary identifying numbers	12773

Submission date: 10/07/2014
Registration date: 10/07/2014
Last edited: 04/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/trials/a-study-looking-care-package-people-having-chemoradiotherapy-cervical-cancer-bladder-cancer

Contact information

Mr Ian Emerson
Scientific

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Email	Ian.emerson@christie.nhs.uk

Study information

Study design	Non-randomised; Interventional and Observational; Design type: Not specified, Process of Care, Cohort study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The clinical benefit and cost effectiveness of a gastrointestinal care bundle for patients undergoing pelvic chemoradiotherapy: a randomised controlled pilot study
Study objectives	The specific aim of this pilot study is to test the process of recruitment, randomisation, investigation, treatment and follow up assessments and to provide provisional data on which to design and power a multicentre randomised controlled trial to determine if a gastrointestinal care bundle, including nutritional intervention and detecting and treating lactose intolerance, small bowel bacterial overgrowth and bile acid malabsorption, improves GI symptoms in the short-term.
Ethics approval(s)	12/NW/0160
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Bladder Cancer, Gynaecological Cancer; Disease: Bladder (advanced), Bladder (superficial), Cervix
Intervention	Gastrointestinal Care Bundle, Nutritional intervention and detecting and treating lactose intolerance, small bowel bacterial overgrowth and bile acid malabsorption Study Entry : Single Randomisation only
Intervention type	Other
Primary outcome measure	Gastrointestinal symptoms as determined by CTCAE pelvic symptom questionnaire; Timepoint(s): Immediately post-treatment (week 6)
Secondary outcome measures	Not provided at time of regsitration
Overall study start date	06/12/2012
Completion date	01/10/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 60; UK Sample Size: 60
Total final enrolment	50
Key inclusion criteria	1. Age =18 years 2. Histologically confirmed cervical or bladder cancer 3. Patients undergoing potentially curative chemoradiotherapy 4. Ability to give informed consent to participate
Key exclusion criteria	1. Age <18 years 2. No histological diagnosis of cervical or bladder cancer 3. Patients unable to complete patient-reported questionnaires 4. Unable to give informed consent 5. Pre-existing GI disease
Date of first enrolment	06/12/2012
Date of final enrolment	01/10/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

550 Wilmslow Road

Manchester
M20 4BX
United Kingdom

Sponsor information

Christie Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

550 Wilmslow Road
Manchester
M20 4BX
England
United Kingdom

"ROR"	https://ror.org/03v9efr22

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2020	04/11/2020	Yes	No

Editorial Notes

04/11/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
31/05/2019: Internal review.
09/11/2017: No publications found, verifying study status with principal investigator.