Efficacy of a zinc mouthwash in prevention of head and neck radiotherapy-induced-oral mucositis: A double-blind randomized placebo-controlled trial
Phase 3
Recruiting
- Conditions
- oral mucositis.Oral mucositis (ulcerative)ICD-70
- Registration Number
- IRCT20190123042475N1
- Lead Sponsor
- Bojnourd University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
All the cancer patients over 18 treated by radiotherapy
Exclusion Criteria
Incidence of co-existing systematic diseases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Creating mucositis based on clinical manifestations (Clinical presentation), severity of mucositis based on the WHO benchmark. Timepoint: In the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: To test mucositis, the WHO classification system is divided into five degrees Grade 0 : None Grade 1 :Soreness + / - Erythema Grade 2 : Erythema , ulcer , patients can swallow solid diet Grade 3 : Ulcer , Extensive erythema , patients can not swallow solid diet Grade 4 : Mucositis to the extent that alimentation is not possible.
- Secondary Outcome Measures
Name Time Method Patients' quality of life and complications. Timepoint: at the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: Quality of life will also be measured using a questionnaire used in previous studies, which measures 0 to 4:Grade 0 (Complications have no effect on daily activities), Grade 1 (Symptoms cause discomfort at least once a week)Grade 2 (symptoms interact with your daily activities more than once a week), Grade 3 (symptoms also interfere with basic activities of life)Grade 4 (symptoms are such that the patient is afraid to leave the home, leading a sharp reduction in the individual's social activities.