Clinical trial NCT00814359: Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Mucositis
Keywords: mucositis
radiation
magic mouthwash
sucralfate
benzydamine
diphenhydramine
dexamethasone
nystatin
Lead sponsor: Juravinski Cancer Centre Foundation
Sponsor class: OTHER
First posted: 2008-12-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. This study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.

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, 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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Baseline to 6 weeks after the initiation of radiotherapy.
Secondary outcomes:
measure: The severity of patient-reported symptoms of mucositis throughout the course radiotherapy as determined by the area under the curve for mean change in OMWQ-HN scores from baseline.
timeFrame: Baseline to 10 weeks after initiating radiotherapy.
measure: Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy.
timeFrame: 4 weeks after initiating radiotherapy
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre
name: Joda Kuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein JB, Silverman S Jr, Paggiarino DA, Crockett S, Schubert MM, Senzer NN, Lockhart PB, Gallagher MJ, Peterson DE, Leveque FG. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001 Aug 15;92(4):875-85. doi: 10.1002/1097-0142(20010815)92:43.0.co;2-1.
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citation: Etiz D, Erkal HS, Serin M, Kucuk B, Hepari A, Elhan AH, Tulunay O, Cakmak A. Clinical and histopathological evaluation of sucralfate in prevention of oral mucositis induced by radiation therapy in patients with head and neck malignancies. Oral Oncol. 2000 Jan;36(1):116-20. doi: 10.1016/s1368-8375(99)00075-5.
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