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

NCT00814359 | Completed Phase 3

• 1 other identifier: MUCOSA-PROTECT
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Mucositis

Keywords

mucositis; radiation; magic mouthwash; sucralfate; benzydamine; diphenhydramine; dexamethasone; nystatin

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 weeks after the initiation of radiotherapy.

Secondary Outcomes (2)

• 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.

  Baseline to 10 weeks after initiating radiotherapy.

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

  4 weeks after initiating radiotherapy

Study Arms (2)

Magic Mouthwash Plus Sucralfate

EXPERIMENTAL

Drug: Combination of Magic Mouthwash Plus Sucralfate

Benzydamine HCl

ACTIVE COMPARATOR

Drug: 0.15% Benzydamine HCl

Interventions

Combination of Magic Mouthwash Plus Sucralfate DRUG

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.

Also known as: Mucositis Mouthwash, Sulcrate

Magic Mouthwash Plus Sucralfate

0.15% Benzydamine HCl DRUG

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.

Also known as: Tantum

Benzydamine HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juravinski Cancer Centre Foundation: lead

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (10)

• 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.

  PMID: 11550161 BACKGROUND

• 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. doi: 10.1002/cncr.22620.

  PMID: 17377917 BACKGROUND

• 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. doi: 10.1016/j.clon.2003.07.002.

  PMID: 14690003 BACKGROUND

• 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. doi: 10.1016/s0360-3016(00)01456-5.

  PMID: 11240232 BACKGROUND

• 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. doi: 10.1002/cncr.20162.

  PMID: 15108222 BACKGROUND

• 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. doi: 10.1177/154405910608500802.

  PMID: 16861284 BACKGROUND

• 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. doi: 10.1002/14651858.CD000978.pub3.

  PMID: 17943748 BACKGROUND

• Rothwell BR, Spektor WS. Palliation of radiation-related mucositis. Spec Care Dentist. 1990 Jan-Feb;10(1):21-5. doi: 10.1111/j.1754-4505.1990.tb01082.x.

  PMID: 1689512 BACKGROUND

• 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.

  PMID: 10889930 BACKGROUND

• Cengiz M, Ozyar E, Ozturk 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. doi: 10.1097/00004836-199901000-00009.

  PMID: 9916664 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Mucositis

Interventions

Sucralfate; Benzydamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joda Kuk, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: May 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 20, 2011

Record last verified: 2009-05

Locations

CA (1)