Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrogen Chloride (HCl) for the Treatment of Radiation-Induced Mucositis - Full Text View

Sponsor:	Juravinski Cancer Centre Foundation
Information provided by:	Juravinski Cancer Centre Foundation
ClinicalTrials.gov Identifier:	NCT00814359

Purpose

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	Intervention	Phase
Head and Neck Cancer Mucositis	Drug: Combination of Magic Mouthwash Plus Sucralfate Drug: 0.15% Benzydamine HCl	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase 3 Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-Induced Oral Mucositis in Head and Neck Cancer Patients.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Sucralfate Diphenhydramine citrate Benzydamine hydrochloride Diphenhydramine hydrochloride Benzydamine

U.S. FDA Resources

Further study details as provided by Juravinski Cancer Centre Foundation:

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy. [ Time Frame: 4 weeks after initiating radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Magic Mouthwash Plus Sucralfate: Experimental	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.
Benzydamine HCl: Active Comparator	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.

Arms

Assigned Interventions

Magic Mouthwash Plus Sucralfate: Experimental

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.

Benzydamine HCl: Active Comparator

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814359

Contacts

Contact: Joda Kuk, MD	(905)387-9495	Joda.Kuk@jcc.hhsc.ca
Contact: Jim Wright, MD	(905)387-9495 ext 64722	Jim.Wright@jcc.hhsc.ca

Locations

Canada, Ontario
Juravinski Cancer Centre	Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Joda Kuk, MD (905)387-9495 Joda.Kuk@jcc.hhsc.ca
Contact: Jim Wright, MD (905)387-9495 ext 64722 Jim.Wright@jcc.hhsc.ca
Principal Investigator: Joda Kuk, MD

Sponsors and Collaborators

Juravinski Cancer Centre Foundation

Investigators

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.

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.

Responsible Party:	Juravinski Cancer Centre ( Dr. Joda Kuk, Principal Investigator )
Study ID Numbers:	MUCOSA-PROTECT
Study First Received:	December 23, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00814359 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Juravinski Cancer Centre Foundation:

mucositis
radiation
magic mouthwash
sucralfate

benzydamine
diphenhydramine
dexamethasone
nystatin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Mouth Diseases
Sucralfate
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Anesthetics
Antiemetics
Benzydamine
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Hypnotics and Sedatives

Mucositis
Gastrointestinal Agents
Central Nervous System Depressants
Histamine Agents
Anti-Allergic Agents
Anesthetics, Local
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Histamine Antagonists
Autonomic Agents
Head and Neck Neoplasms
Histamine H1 Antagonists
Stomatognathic Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010