Comparison the effect of saffron extract with artificial saliva on alleviation of oral mucositis caused by head and neck radiotherapy: a randomized trial

Phase 3

Conditions: Oral mucositis.
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C00-D48

Registration Number: IRCT20221207056743N1

Lead Sponsor: Ghoum University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 62

Inclusion Criteria

People's satisfaction with the trial
Patients with head and neck cancers undergoing radiotherapy
Have received at least 36-40 Gy of radiation
At least 4 weeks have passed since the start of their radiotherapy treatment.
Not allergic to saffron
Absence of heart diseases and blood pressure

Exclusion Criteria

Suffering from other oral and dental diseases.
Long-term use of anti-coagulant and anti-platelet drugs.
Systemic conditions such as pregnancy and breastfeeding, diabetes, hypertension, autoimmune diseases, GVHD, use of saliva reducing drugs, alcohol use, drug addiction, bone marrow transplantation, active lesion, oral infection and mucosal wounds before starting radiotherapy
Lack of consent to continue the trial and lack of consent to continue the treatment.
Performing any surgery and trauma
Suffering from any heart, liver and kidney failure and any disease that has manifestations similar to oral mucositis.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral mucositis score. Timepoint: Start time, day 7?14?21?28. Method of measurement: WHO definition of oral mucositis grading: 0_none 1_pain and redness 2_redness, wound, ability to eat solid foods 3_wound, need for liquid diet 4_feeding impossible.;Pain sevirity. Timepoint: Start time, day 7?14?21?28. Method of measurement: Pain Visual analogue scale.;Teeth color. Timepoint: Starting day and day 28. Method of measurement: Vita shade guide.

Secondary Outcome Measures