Condition category
Cancer
Date applied
10/07/2014
Date assigned
10/07/2014
Last edited
19/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Ian Emerson

ORCID ID

Contact details

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
Ian.emerson@christie.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12773

Study information

Scientific title

Acronym

Gastrointestinal care for patients undergoing pelvic chemoradiotherapy

Study hypothesis

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

12/NW/0160

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 controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

06/12/2012

Overall trial end date

01/10/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant 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

Recruitment start date

06/12/2012

Recruitment end date

01/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Christie Hospital NHS Foundation Trust (UK)

Sponsor details

550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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