IRCT20180103038199N6
Not yet recruiting
Phase 2
Evaluation of the effectiveness of mucoadhesive mouthwash containing saffron petal extract on prevention and improvement of clinical symptoms of radiotherapy-induced oral mucositis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mashhad University of Medical Sciences
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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