Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
17/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Claire Hitchinson

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
claire.hitchinson@rdehc-tr.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203139308

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Double centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2004

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 Subjects from the Royal Devon & Exeter (RD&E) Healthcare Trust and South Devon Healthcare Trust,

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

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Devon and Exeter NHS 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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17131132

Publication citations

  1. Results

    Barber C, Powell R, Ellis A, Hewett J, Comparing pain control and ability to eat and drink with standard therapy vs Gelclair: a preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis., Support Care Cancer, 2007, 15, 4, 427-440, doi: 10.1007/s00520-006-0171-1.

Additional files

Editorial Notes