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Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

Primary Purpose

Head and Neck Cancer, Mucositis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Combination of Magic Mouthwash Plus Sucralfate
0.15% Benzydamine HCl
Sponsored by
Juravinski Cancer Centre Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring mucositis, radiation, magic mouthwash, sucralfate, benzydamine, diphenhydramine, dexamethasone, nystatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Juravinski Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magic Mouthwash Plus Sucralfate

Benzydamine HCl

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy.

Full Information

First Posted
December 23, 2008
Last Updated
January 19, 2011
Sponsor
Juravinski Cancer Centre Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00814359
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Juravinski Cancer Centre Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Mucositis
Keywords
mucositis, radiation, magic mouthwash, sucralfate, benzydamine, diphenhydramine, dexamethasone, nystatin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magic Mouthwash Plus Sucralfate
Arm Type
Experimental
Arm Title
Benzydamine HCl
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Combination of Magic Mouthwash Plus Sucralfate
Other Intervention Name(s)
Mucositis Mouthwash, Sulcrate
Intervention Description
Magic mouthwash will contain diphenhydramine powder 375mg, dexamethasone injection 2.8mg, and nystatin suspension 50ml (1000 units/ml) diluted to a total volume of 250ml with sterile water. The concentration of the sucralfate suspension will be 1g/5ml. Patients will be instructed to rinse first with 5ml of the magic mouthwash solution for 2 minutes then swallow, followed by rinsing with 5ml of the sucralfate suspension for 2 minutes before swallowing, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
0.15% Benzydamine HCl
Other Intervention Name(s)
Tantum
Intervention Description
Patients will rinse with 15ml of 1.5mg/ml benzydamine HCl for 2 minutes then expectorate the solution, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.
Primary Outcome Measure Information:
Title
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.
Time Frame
Baseline to 6 weeks after the initiation of radiotherapy.
Secondary Outcome Measure Information:
Title
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.
Time Frame
Baseline to 10 weeks after initiating radiotherapy.
Title
Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy.
Time Frame
4 weeks after initiating radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joda Kuk, MD
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11550161
Citation
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Results Reference
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PubMed Identifier
17377917
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

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