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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.

Phase 3
18 Years
Not Enrolling
Head and Neck Cancer, Mucositis

Thank you

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

- Patient is unable or unwilling to complete the questionnaires which are written in

- 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:


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:


Principal Investigator

Joda Kuk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Juravinski Cancer Centre


Canada: Ethics Review Committee

Study ID:




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