Status:
COMPLETED
Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis
Lead Sponsor:
Juravinski Cancer Centre Foundation
Conditions:
Head and Neck Cancer
Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due...
Detailed Description
Sixty patients with head and neck cancer being treated with 6 or more weeks of radiotherapy, will be randomly assigned to receive either a combination of magic mouthwash (diphenhydramine, dexamethason...
Eligibility Criteria
Inclusion
- Histologically proven squamous cell carcinoma of the head and neck.
- Receiving 6 or more weeks of external beam radiotherapy to a treatment volume that includes mucosal surfaces of the head and neck.
Exclusion
- Age less than 18 years
- ECOG Performance Score 2 or higher
- Patient is unable to understand the protocol and/or unable to provide informed consent
- Patient is unable or unwilling to complete the questionnaires which are written in English.
- Prior radiation to the head and neck region that would result in overlap of fields for the current study.
- Plan to receive a radiation treatment volume that only includes the larynx and or hypopharynx with no planned treatment of locoregional lymph nodes.
- Plan to receive a concurrent chemotherapy agent other than cisplatin.
- Plan to receive other investigational agents (eg. panitumumab).
- Investigational agent of any kind within 30 days prior to randomization.
- Concurrent administration of any other experimental intervention given for the purpose of preventing oral mucositis.
- History of allergic or hypersensitivity reactions to any of the possible agents to be administered in the study.
- Patients who are pregnant or lactating.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00814359
Start Date
May 1 2009
End Date
September 1 2010
Last Update
January 20 2011
Active Locations (1)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2