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

Primary Purpose

Stomatitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
2% morphine solution
Magnesium aluminum hydroxide
2% viscous lidocaine
Diphenhydramine
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomatitis focused on measuring mucositis, topical morphine, pain, head and neck carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiation Oncology Department, Seyed Al-Shohada Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Morphine mouthwash

Magic mouthwash

Arm Description

The morphine group uses the mouthwash of 2% morphine solution (20 mg morphine sulfate diluted in 100 mL of water), 10 mL every three hours; six times a day. The morphine solution is prepared by the faculty of pharmacy under supervision of the Food and Drug Organization of the local Medical University.

The magic group uses a mouthwash contained a mixture of 240 mL magnesium aluminum hydroxide (Alborz Co., Iran), 25 mL 2% viscous lidocaine (SinaDaru Co., Iran), and 60 mL diphenhydramine (Emad Co., Iran), 10 mL every three hours; six times a day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 26, 2013
Last Updated
April 22, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01837446
Brief Title
Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomatitis
Keywords
mucositis, topical morphine, pain, head and neck carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine mouthwash
Arm Type
Experimental
Arm Description
The morphine group uses the mouthwash of 2% morphine solution (20 mg morphine sulfate diluted in 100 mL of water), 10 mL every three hours; six times a day. The morphine solution is prepared by the faculty of pharmacy under supervision of the Food and Drug Organization of the local Medical University.
Arm Title
Magic mouthwash
Arm Type
Active Comparator
Arm Description
The magic group uses a mouthwash contained a mixture of 240 mL magnesium aluminum hydroxide (Alborz Co., Iran), 25 mL 2% viscous lidocaine (SinaDaru Co., Iran), and 60 mL diphenhydramine (Emad Co., Iran), 10 mL every three hours; six times a day.
Intervention Type
Drug
Intervention Name(s)
2% morphine solution
Intervention Type
Drug
Intervention Name(s)
Magnesium aluminum hydroxide
Intervention Type
Drug
Intervention Name(s)
2% viscous lidocaine
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Primary Outcome Measure Information:
Title
Mucositis severity
Description
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.
Time Frame
Up to six days
Secondary Outcome Measure Information:
Title
Patient's satisfaction
Description
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.
Time Frame
After six days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simin Hemati, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiation Oncology Department, Seyed Al-Shohada Hospital
City
Isfahan
ZIP/Postal Code
81849-17395
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
12412178
Citation
Cerchietti LC, Navigante AH, Bonomi MR, Zaderajko MA, Menendez 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. doi: 10.1002/cncr.10938. Erratum In: Cancer. 2003 Feb 15;97(4):1137.
Results Reference
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PubMed Identifier
16909245
Citation
Cerchietti L. Morphine mouthwashes for painful mucositis. Support Care Cancer. 2007 Jan;15(1):115-6; author reply 117. doi: 10.1007/s00520-006-0124-8. Epub 2006 Aug 15. No abstract available.
Results Reference
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Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer

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