A preliminary, double centre, randomised controlled trial on patients with radiotherapy induced oral mucositis
| ISRCTN | ISRCTN36247249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36247249 |
| Protocol serial number | N0203139308 |
| Sponsor | Department of Health |
| Funder | Royal Devon and Exeter NHS Trust (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Miss Claire Hitchinson
Scientific
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
| claire.hitchinson@rdehc-tr.swest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
