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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN36247249 |
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Date of registration:
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30/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A preliminary, double centre, randomised controlled trial on patients with radiotherapy induced oral mucositis
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Scientific title:
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Date of first enrolment:
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01/03/2004 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN36247249 |
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Study type:
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Interventional |
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Study design:
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Double centre randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Claire
Hitchinson |
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Address:
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Royal Devon & Exeter Hospital (Wonford)
Barrack Road
EX2 5DW
Exeter
United Kingdom |
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Telephone:
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Email:
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claire.hitchinson@rdehc-tr.swest.nhs.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Radiotherapy induced mucositis
Cancer
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0203139308
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Source(s) of Monetary Support
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Royal Devon and Exeter NHS Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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