The effect of saffron on mucositis
Phase 2
- Conditions
- Radiotherapy-induced oral mucositis.Oral mucositis (ulcerative) due to radiationK12.33
- Registration Number
- IRCT20180103038199N6
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients treated for head and neck cancer with chemo-radiotherapy
Age between 18 and 70 years
Absence of serious dental problems
Absence of impacted teeth
No cusp or sharp filling
Total radiation is between 50 and 70 Gy during treatment
Exposure of at least half of the oral cavity to radiation
Patients should take one of the drugs cisplatin or 5-fluorouracil in their chemotherapy regimen.
Exclusion Criteria
Severe infections that require antibiotics.
Patients who have been allergic to any of the herbal extracts or previous radiotherapy
Inability of the patient to implement the treatment protocol
Renal failure (eGFR <50 ml / min)
Liver failure (serum level 2 to 3 times higher than normal)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mucositis score based on World Health Organization scoring. Timepoint: Every week from the beginning of the drug (week zero) to the end of the study (week seven). Method of measurement: World Health Organization mucositis scoring questionnaire.
- Secondary Outcome Measures
Name Time Method