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

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ClinicalTrials.gov Identifier: NCT00814359

Recruitment Status : Completed

First Posted : December 24, 2008

Last Update Posted : January 20, 2011

Sponsor:

Information provided by:

Juravinski Cancer Centre Foundation

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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer Mucositis	Drug: Combination of Magic Mouthwash Plus Sucralfate Drug: 0.15% Benzydamine HCl	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	67 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
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 Start Date :	May 2009
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head and Neck Cancer

Drug Information available for: Sucralfate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Magic Mouthwash Plus Sucralfate	Drug: Combination of Magic Mouthwash Plus Sucralfate 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. Other Names: Mucositis Mouthwash Sulcrate
Active Comparator: Benzydamine HCl	Drug: 0.15% Benzydamine HCl 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. Other Name: Tantum

Arm

Intervention/treatment

Experimental: Magic Mouthwash Plus Sucralfate

Drug: Combination of Magic Mouthwash Plus Sucralfate

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.

Other Names:

Mucositis Mouthwash
Sulcrate

Active Comparator: Benzydamine HCl

Drug: 0.15% Benzydamine HCl

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.

Other Name: Tantum

Outcome Measures

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. [ Time Frame: Baseline to 6 weeks after the initiation of radiotherapy. ]

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. [ Time Frame: Baseline to 10 weeks after initiating radiotherapy. ]
Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy. [ Time Frame: 4 weeks after initiating radiotherapy ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814359

Locations

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Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2

Sponsors and Collaborators

Juravinski Cancer Centre Foundation

Investigators

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Principal Investigator:	Joda Kuk, MD	Juravinski Cancer Centre

More Information

Publications:

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.

Epstein JB, Beaumont JL, Gwede CK, Murphy B, Garden AS, Meredith R, Le QT, Brizel D, Isitt J, Cella D. Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire. Cancer. 2007 May 1;109(9):1914-22.

Wright JR, McKenzie M, DeAngelis C, Foroudi F, Paul N, Rajaraman M, Wong F, Wong R, Wong KS. Radiation induced mucositis: co-ordinating a research agenda. Clin Oncol (R Coll Radiol). 2003 Dec;15(8):473-7.

Sutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):917-30.

Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. Review.

Stokman MA, Spijkervet FK, Boezen HM, Schouten JP, Roodenburg JL, de Vries EG. Preventive intervention possibilities in radiotherapy- and chemotherapy-induced oral mucositis: results of meta-analyses. J Dent Res. 2006 Aug;85(8):690-700. Review.

Worthington HV, Clarkson JE, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000978. Review. Update in: Cochrane Database Syst Rev. 2010;(12):CD000978.

Rothwell BR, Spektor WS. Palliation of radiation-related mucositis. Spec Care Dentist. 1990 Jan-Feb;10(1):21-5.

Etiz D, Erkal HS, Serin M, Küçük 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.

Cengiz M, Ozyar E, Oztürk D, Akyol F, Atahan IL, Hayran M. Sucralfate in the prevention of radiation-induced oral mucositis. J Clin Gastroenterol. 1999 Jan;28(1):40-3.

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Responsible Party:	Dr. Joda Kuk, Principal Investigator, Juravinski Cancer Centre
ClinicalTrials.gov Identifier:	NCT00814359
Other Study ID Numbers:	MUCOSA-PROTECT
First Posted:	December 24, 2008 Key Record Dates
Last Update Posted:	January 20, 2011
Last Verified:	May 2009

Keywords provided by Juravinski Cancer Centre Foundation:


mucositis radiation magic mouthwash sucralfate	benzydamine diphenhydramine dexamethasone nystatin

Additional relevant MeSH terms:

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Head and Neck Neoplasms Mucositis Neoplasms by Site Neoplasms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases	Mouth Diseases Stomatognathic Diseases Benzydamine Sucralfate Anti-Inflammatory Agents Anti-Ulcer Agents Gastrointestinal Agents

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