Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36247249
Enrollment
20
Registered
2004-09-30
Start date
2004-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapy induced mucositis Cancer

Interventions

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 recruitme

Sponsors

Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026