Effect of Achillea wilhelmsii oral rinse on chemoradiotherapy induced oral mucositis in head and neck cancers

Phase 3

Conditions: Oral mucositis (Stomatitis).
Stomatitis and related lesions

Registration Number: IRCT20180516039682N3

Lead Sponsor: Zanjan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 36

Inclusion Criteria

Patients with full consciousness
Patients older than 18 years and younger than 60 years
Patients with head and neck malignancies
Patients undergoing chemotherapy and radiotherapy

Exclusion Criteria

Patients with oral mucositis
Patients with any systemic diseases other than head and neck malignancies
Patients with a history of allergy to Achillea wilhelmsii and medicinal plants
Patients with a history of chemotherapy or radiotherapy
Patients with xerostomia
Use of drugs that reduce salivation
Use of antibiotics, antifungals and systemic anti-inflammatory drugs
Patients with malnutrition
Smoking and alcohol consumption
Use of dentures

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset time of oral mucositis. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Clinical examination by a dentist based on World Health Organization oral mucositis grading scale.;Severity of oral mucositis. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Clinical examination by a dentist based on World Health Organization oral mucositis grading scale.

Secondary Outcome Measures

Name	Time	Method
Patient's weight. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Using a digital scale.;Severity of oral pain. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Questionnaire.;Satisfaction with mouthwash. Timepoint: Days 0, 7, 14, 21 and 28 after starting cancer treatment. Method of measurement: Questionnaire.