Fifty patients with head and neck cancer who recieve reffer to Cancer Institute of Imam Khomeini Hospital will divide into two groups by balanced block randomization method and will receive green tea mouthwash (intervention group) and normal saline mouthwash (control group). During 8week period of radiotherapy, all the patients will be examined once a week and any erythema, ulcers and mouth burns (VAS) will be recorded by a blind examiner. Finally results of both groups will be compared to each other and will be analyzed statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013090914606N1
Registration date:2014-04-27, 1393/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-27, 1393/02/07
Registrant information
Name
Shiva Shirazian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 721 0537
Email address
shiraziansh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-02-18, 1391/11/30
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Green tea mouth rinse on radiation-induced mucositis in patients with head and neck cancer:A Randomized clinical trial
Public title
Effectiveness of Green tea mouth rinse on radiation-induced mucositis in patients with head and neck cancer
Purpose
Prevention
Inclusion/Exclusion 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.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods st., Keshavarz boulevard
City
Tehran
Postal code
Approval date
2014-02-18, 1392/11/29
Ethics committee reference number
92-03-69-21298-106779
Health conditions studied
1
Description of health condition studied
Radiation induced oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Mucositis(oral) (oropharyngeal): NOS
Primary outcomes
1
Description
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
2
Description
sex
Timepoint
before the beginning of study
Method of measurement
observation
3
Description
Weight
Timepoint
At the beginning and end of radiotherapy
Method of measurement
Scaler
4
Description
Received radiation dose
Timepoint
The total dose received during the meetings
Method of measurement
Grey
5
Description
age
Timepoint
at the beginning of study
Method of measurement
year
6
Description
Name of cancer
Timepoint
Before the beginning of study
Method of measurement
Pathology report
7
Description
Cancer location
Timepoint
Before the beginning of study
Method of measurement
Medical records
Secondary outcomes
1
Description
Pain and soreness
Timepoint
Every week
Method of measurement
Visual analogue scale
2
Description
Mucositis grading
Timepoint
Every week
Method of measurement
WHO grading(0-4)
Intervention groups
1
Description
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 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeyni Hospital
Full name of responsible person
Soheila Manifar
Street address
Imam Khomeyni hospital, Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Vice chancellor for research, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azeen Rashtiyani
Position
Student of dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar st.