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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Stomatitis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Mucositis severity

Outcome 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.

Outcome Time Frame:

Up to six days

Safety Issue:

No

Principal Investigator

Simin Hemati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Isfahan University of Medical Sciences

Authority:

Iran: Ministry of Health

Study ID:

390163

NCT ID:

NCT01837446

Start Date:

July 2011

Completion Date:

October 2012

Related Keywords:

  • Stomatitis
  • mucositis
  • topical morphine
  • pain
  • head and neck carcinoma
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

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