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

Effectiveness of Green tea mouth rinse on radiation-induced mucositis in patients with head and neck cancer:A Randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013090914606N1
Enrollment
50
Registered
2014-04-27
Start date
2013-02-18
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation induced oral mucositis. Mucositis(oral) (oropharyngeal): NOS

Interventions

Green tea mouth rinse with 3%concentration in the intervention group for the prevention of radiation induced mucositis and 0.9% saline were used as controls. These interventions will continue for 8
Prevention

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Secondary

MeasureTime frame
Pain and soreness. Timepoint: Every week. Method of measurement: Visual analogue scale.;Mucositis grading. Timepoint: Every week. Method of measurement: WHO grading(0-4).

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzeen Rashtiyani

Tehran University of Medical Sciences

aazeanrashtiani.den@gmail.com; azin_ra2000@yahoo.com+98 21 8474 2136

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026