A preliminary, double centre, randomised controlled trial on patients with radiotherapy induced oral mucositis

ISRCTN	ISRCTN36247249
DOI	https://doi.org/10.1186/ISRCTN36247249
Secondary identifying numbers	N0203139308

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 17/05/2012

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

Not provided at time of registration

Contact information

Miss Claire Hitchinson
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Email	claire.hitchinson@rdehc-tr.swest.nhs.uk

Study information

Study design	Double centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study hypothesis	The use of Gelclair in the management of patients with radiotherapy induced mucositis, will significantly reduced levels of intro-oral pain and consequently improve the patients' ability to eat and drink
Ethics approval(s)	Not provided at time of registration
Condition	Radiotherapy induced mucositis
Intervention	Randomised controlled trial. A sample of patients who are due to receive radiotherapy to the Head and Neck and who would normally be expected to develop oral mucositis will be approached for recruitment into the study. 20 Subjects from the Royal Devon & Exeter (RD&E) Healthcare Trust and South Devon Healthcare Trust, who fit the criteria for the study, will be selected and then randomly assigned to one of two treatment arms. The treatment groups will receive Gelclair plus standard therapy and the control groups will receive standard therapy alone. A baseline questionnaire will be completed before the patient starts taking their treatment regime and then subsequently re-completed at 1 hour, 3 hours and 24 hours. The independent variables to be measured will be A. Standard Therapy, B Gelclair. The dependent variables to be measured will be A. Patients pain levels at baseline, 1, 3 and 24 hours respectively, B. Patients ability to eat and drink at baseline, 1, 3, & 24 hours respectively.
Intervention type	Other
Primary outcome measure	This study aims to evaluate short-term symptom control offered by Standard Therapy vs Gelclair, in patients suffering from radiotherapy-induced oral mucositis. Due to the escalating nature of this condition, the trial will be conducted over a period of 24 hours only. Study endpoints: Comparing 1. Patients' inability to eat and drink 2. Pain levels In control and treatment groups
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2004
Overall study end date	30/09/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20 Subjects from the Royal Devon & Exeter (RD&E) Healthcare Trust and South Devon Healthcare Trust,
Participant inclusion criteria	A sample of patients who are due to receive radiotherapy to the Head and Neck and who would normally be expected to develop oral mucositis, will be approached for recruitment into the study. 20 subjects from the RD&E Healthcare Trust and South Devon Healthcare Trust, who fit the criteria for the study, will be selected and then randomly assigned to one of two treatment arms.
Participant exclusion criteria	Those unable to give informed consent, patients who are known to be allergic to any of the constituents of Gelclair or standard therapy, those under the age of 18 years.
Recruitment start date	01/03/2004
Recruitment end date	30/09/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter
EX2 5DW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Royal Devon and Exeter NHS 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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No