Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT01837446|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stomatitis||Drug: 2% morphine solution Drug: Magnesium aluminum hydroxide Drug: 2% viscous lidocaine Drug: Diphenhydramine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 Start Date :||July 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Morphine mouthwash
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.
|Drug: 2% morphine solution|
Active Comparator: Magic mouthwash
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.
|Drug: Magnesium aluminum hydroxide Drug: 2% viscous lidocaine Drug: Diphenhydramine|
- Mucositis severity [ Time Frame: Up to six days ]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.
- Patient's satisfaction [ Time Frame: After six days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837446
|Iran, Islamic Republic of|
|Radiation Oncology Department, Seyed Al-Shohada Hospital|
|Isfahan, Iran, Islamic Republic of, 81849-17395|
|Principal Investigator:||Simin Hemati, MD||Isfahan University of Medical Sciences|