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Effectiveness of Green tea mouth rinse on radiation-induced mucositis in patients with head and neck cancer

Phase 2
Conditions
Radiation induced oral mucositis.
Mucositis(oral) (oropharyngeal): NOS
Registration Number
IRCT2013090914606N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
Inclusion Criteria

patients older than 18 years old; patients that are diagnosed with the head and neck cancer; minimum dose of radiation therapy must be 50Gy to induce mucositis; patients who are able to use mouthwash before radiotherapy session; patients sign informed consent; at least 50% of the oral cavity area should be under radiation fields; having an ideal oral hygiene; absence of active infection in the oral cavity such as HSV, candida and aphthous ulcers. Exclusion criteria: patients currently suffering from any kind of oral diseases, e.g. active oral infection, ulcer, etc.; patients receiving chemotherapy combined with radiotherapy patients that are not able to use mouthwash; patients who have a broad extent of the lesions and grade IV mucositis; patients who use local anesthetic in the study; patients who are not willing to leave their unsafe habits such as smoking, alcohol, spicy and acidic foods; patients with a history of allergy to green tea; patients with lesions in the oral cavity area; patients who recently have used prostaglandin inhibitors, vitamin E and antioxidant supplements; lack of cooperation at every stage of project.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Type of mouthwash for treatment. Timepoint: after the termination of study. Method of measurement: revealing the mouth wash anyone was receiving after the end of study.;Sex. Timepoint: before the beginning of study. Method of measurement: observation.;Weight. Timepoint: At the beginning and end of radiotherapy. Method of measurement: Scaler.;Received radiation dose. Timepoint: The total dose received during the meetings. Method of measurement: Grey.;Age. Timepoint: at the beginning of study. Method of measurement: year.;Name of cancer. Timepoint: Before the beginning of study. Method of measurement: Pathology report.;Cancer location. Timepoint: Before the beginning of study. Method of measurement: Medical records.
Secondary Outcome Measures
NameTimeMethod
Pain and soreness. Timepoint: Every week. Method of measurement: Visual analogue scale.;Mucositis grading. Timepoint: Every week. Method of measurement: WHO grading(0-4).
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