A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.
18 Years
N/A
Both
Head and Neck Cancer, Mucositis
Trial Information
A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.
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, dexamethasone and nystatin) plus sucralfate or benzydamine. Patients
randomized to receive magic mouthwash plus sucralfate will rinse first with 5ml of the magic
mouthwash for 2 minutes then swallow, followed by rinsing with 5ml of the 1g/5ml sucralfate
for 2 minutes before swallowing, 4 times daily. Patients randomized to receive 0.15%
benzydamine HCl will be instructed to rinse with 15ml of the solution for 2 minutes before
expectorating, 4 times daily. Patients will start the mouthwash regimens prior to the
initiation of radiotherapy, and stop 2 weeks after the completion of radiotherapy.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
The severity of patient-reported symptoms of mucositis as determined by the change in Oral Mucositis Weekly Questionnaire - Head and Neck Cancer (OMWQ-HN) score from baseline to 6 weeks.
Outcome Time Frame:
Baseline to 6 weeks after the initiation of radiotherapy.
Safety Issue:
No
Principal Investigator
Joda Kuk, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Juravinski Cancer Centre
Authority:
Canada: Ethics Review Committee
Study ID:
MUCOSA-PROTECT
NCT ID:
NCT00814359
Start Date:
May 2009
Completion Date:
September 2010
Related Keywords:
- Head and Neck Cancer
- Mucositis
- mucositis
- radiation
- magic mouthwash
- sucralfate
- benzydamine
- diphenhydramine
- dexamethasone
- nystatin
- Head and Neck Neoplasms
- Mucositis
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