Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer

Stomatitis Clinical Trial

Official title:

Evaluating the Effectiveness of Topical Morphine Compared With a Routine Mouthwash in Managing Cancer Treatment-induced Mucositis in Patients With Head and Neck Cancer in Isfahan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837446
• Other study ID #: 390163
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 26, 2013
• Last updated: April 22, 2013
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Oral mucositis is a debilitating side effects of cancer treatment for which there is not much successful treatments at yet. The investigators are going to evaluate the effectiveness of topical morphine compared with a routine mouthwash in managing cancer treatment-induced mucositis. The investigators hypothesize that topical morphine is more effective and more satisfied by patients than the magic mouthwash in reducing severity of cancer treatment-induced oral mucositis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Head and neck cancer patients

• Severe oral mucositis; grade III or IV of the World Health Organization (WHO) rating of global mucositis

• Willingness to participate

Exclusion Criteria:

• History of severe renal or hepatic insufficiency

• Collagen-vascular disease

• Allergic reaction to morphine

• Current smokers or alcohol users

• Pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Stomatitis

Intervention

Drug:
• 2% morphine solution

• Magnesium aluminum hydroxide

• 2% viscous lidocaine

• Diphenhydramine

Locations

Country	Name	City	State
Iran, Islamic Republic of	Radiation Oncology Department, Seyed Al-Shohada Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

Cerchietti L. Morphine mouthwashes for painful mucositis. Support Care Cancer. 2007 Jan;15(1):115-6; author reply 117. Epub 2006 Aug 15. — View Citation

Cerchietti LC, Navigante AH, Bonomi MR, Zaderajko MA, Menéndez PR, Pogany CE, Roth BM. Effect of topical morphine for mucositis-associated pain following concomitant chemoradiotherapy for head and neck carcinoma. Cancer. 2002 Nov 15;95(10):2230-6. Erratum in: Cancer. 2003 Feb 15;97(4):1137.. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucositis severity	Patients are visited by a radiation oncologist at baseline, 3rd day, and 6th day of the intervention. The WHO grading system of mucositis is administered for each patient in which, 0 indicates a healed mucositis and no signs or symptoms, 1 indicates mild soreness but not problem in eating, 2 indicates painful erythema, edema, or ulcers but able to eat, 3 indicates severe painful erythema, edema, or ulcers and having problem in eating, and 4 indicates if there is a requirement for parenteral or enteral support.	Up to six days	No
Secondary	Patient's satisfaction	Patients also are asked about if pain/discomfort relived by mouthwash and if so for how long (< 1 h, 1 to 2 h, > 2 h). Their satisfaction with treatment is graded as satisfied, tolerable, and intolerable.	After six days	No