Selenium in radiochemotherapy mucositis
Phase 2
- Conditions
- Condition 1: Malignant melanoma of other and unspecified parts of face. Condition 2: Malignant neoplasm of nasal cavity and middle ear. Condition 3: Malignant neoplasm of accessory sinuses. Condition 4: Malignant neoplasm of larynx. Condition 5: Malignant melanoma of lip.Malignant melanoma of other and unspecified parts of faceMalignant neoplasm of nasal cavity and middle earMalignant neoplasm of accessory sinusesMalignant neoplasm of larynxMalignant melanoma of lip
- Registration Number
- IRCT2014072718612N1
- Lead Sponsor
- Research Center of Rational Drug Use
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
inclusion criteria:age over 18 years old;head and neck carcinoma ;radiocemotherapy candidate;liver and kidney normal condition;at least two third of oral cavity is exposed radiotherapy
exclusion criteria:under 18 years old;prior history of using selenium;kidney and hepatic failure
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucositis. Timepoint: 7days after interventionn and then weekly and 7 days after finshing intervention. Method of measurement: Physical examination.;Selenium blood level. Timepoint: prior of radiation start and at the end of radiotherapy sessions. Method of measurement: Spectrophotometry.;Neutropenia. Timepoint: prior of selenium start and at the end of radiotherapy sessions. Method of measurement: blood level.;Mucositis length. Timepoint: 7days after interventionn and then weekly and 7 days after finshing intervention. Method of measurement: observation.
- Secondary Outcome Measures
Name Time Method po(non per oral) time. Timepoint: 7 days after intervention and then weekly. Method of measurement: Physical examination.;Narcotic use. Timepoint: weekly. Method of measurement: observation.;Weight. Timepoint: prior and at the end of selenium use. Method of measurement: kg.