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Sponsored by: |
Juravinski Cancer Centre Foundation |
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Information provided by: | Juravinski Cancer Centre Foundation |
ClinicalTrials.gov Identifier: | NCT00814359 |
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 |
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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. |
Estimated Enrollment: | 60 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Canada, Ontario | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 |
Principal Investigator: | Joda Kuk, MD | Juravinski Cancer Centre |
Responsible Party: | Juravinski Cancer Centre ( Dr. Joda Kuk, Principal Investigator ) |
Study ID Numbers: | MUCOSA-PROTECT |
Study First Received: | December 23, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00814359 |
Health Authority: | Canada: Ethics Review Committee |
mucositis radiation magic mouthwash sucralfate |
benzydamine diphenhydramine dexamethasone nystatin |
Mouth Diseases Dexamethasone Sucralfate Mucositis Gastrointestinal Diseases Nystatin Benzydamine |
Digestive System Diseases Promethazine Head and Neck Neoplasms Stomatognathic Diseases Gastroenteritis Dexamethasone acetate Diphenhydramine |
Anti-Inflammatory Agents Neoplasms Neoplasms by Site Therapeutic Uses |
Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |