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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: |
ISRCTN07033239 |
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Date of registration:
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18/02/2010 |
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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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Comparing benzydamine with placebo in the prevention of radiation-induced mucositis in head and neck cancer patients in Imam Hossein Hospital, Iran
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Scientific title:
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Benzydamine versus placebo in radiation-induced mucositis in patients with head and neck cancer: a phase II randomised controlled trial |
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Date of first enrolment:
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10/06/2009 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN07033239 |
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Study type:
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Interventional |
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Study design:
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Phase II randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Iran
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Contacts
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Name:
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Ahmad
Ameri |
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Address:
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Imam Hossein Hospital
Department of Radiation Oncology
Shahid Madani St
1617763141
Tehran
Iran |
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Telephone:
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+98 (0)21 7755 2056 |
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Email:
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A_Ameri@sbmu.ac.ir |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male and non-pregnant female subjects aged 18 - 80 years
2. Diagnoses of head and neck malignancy
3. Total external beam radiotherapy (RT) dose of at least 5000 cGy via a megavoltage treatment with either a cobalt-60 or a linear accelerator
4. At least two oral mucosal sites included in the planned RT treatment volume
Exclusion criteria: 1. Karnofsky performance status less than 80%
2. Hypersensitivity to benzydamine or typical nonsteroidal anti-inflammatory drugs (NSAIDs)
3. Had taken experimental drugs within 30 days of study start
4. Chronically took steroids, NSAIDs, or other analgesics for other medical conditions
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Head and neck cancer/mucositis
Cancer
Malignant neoplasm of other and ill-defined sites
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Intervention(s)
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Patients will be randomised in two groups (placebo and benzydamine). Subjects were encouraged to brush their teeth at least twice daily, floss once daily, rinse as necessary with bland oral rinses (e.g., normal saline, sodium bicarbonate). Commercial mouthwashes (over the counter or prescription), chlorhexidine, or other agents to aid in oral hygiene were prohibited.
Oral rinsing with study treatments was initiated the day before RT and continued for 2 weeks after the end of RT. 15 ml for 2 minutes, 4 - 8 times daily before and during RT, and for 2 weeks after completion of RT. If burning or stinging occurred, dilution of the rinse with water at 1:1 or 1:2 was allowed. All bottles of study rinse were returned each week and the amount returned recorded.
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Primary Outcome(s)
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Reducing mucositis, measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy)
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Secondary Outcome(s)
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1. Time to grade III mucositis
2. Time to grade IV mucositis
Measured during treatment (from the first day of radiotherapy until one week after termination of radiotherapy).
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Source(s) of Monetary Support
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Imam Hossein Hospital (Iran)
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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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