Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis
NCT ID: NCT00814359
Last Updated: 2011-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
67 participants
INTERVENTIONAL
2009-05-31
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis (Mouth Sores) Resulting From Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, or Nasopharynx
NCT00051441
Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer
NCT01837446
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
NCT01400620
Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
NCT06854510
Comparative Efficacy of Rebamipide Gargle And Benzydamine HCL Gargle in Prevention and Management of Chemo- and Radio-therapy-induced Oral Mucositis
NCT04685395
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Magic Mouthwash Plus Sucralfate
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Receiving 6 or more weeks of external beam radiotherapy to a treatment volume that includes mucosal surfaces of the head and neck.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Juravinski Cancer Centre Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juravinski Cancer Centre
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joda Kuk, MD
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MUCOSA-PROTECT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.