Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced acute mucositis in head and neck cancer patients
Phase 3
- Conditions
- Mucositis.Oral mucositis (ulcerative)
- Registration Number
- IRCT2014120520208N1
- Lead Sponsor
- Vice Chancellor for research of Shahed University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
patients with 17-65 years old in both sexes; candidate for radiotherapy for head & neck cancers; life expectancy over 1 year; Good performance status in ECOG questionnaire; At least 4 areas in RT fields Early
Exclusion criteria: Patients with organic & suppressive disorders; Use of drugs effective on salivary glands, cigar or alcohol; History of Rt in last 6 months; Grade 3-4 Mucositis, candidiasis, oral herpes; Failure to treat, Hospitalization or need to TPN; Lack of interest in work
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucositis. Timepoint: At the baseline, Weeks 1,2,3,4,5,6,7. Method of measurement: Examination of Oral Cavity.;Pain. Timepoint: At the baseline, Weeks 1,2,3,4,5,6,7. Method of measurement: Visual Analogue Scale.;Quality of Life. Timepoint: Weeks 1,2,3,4,5,6,7. Method of measurement: EORTC questionnaire.
- Secondary Outcome Measures
Name Time Method Side Effects. Timepoint: Weeks 1,2,3,4,5,6,7. Method of measurement: Questionnaire.