The objective of this study is to evaluate the effect of Sage officinalis extract on radiation - induced oral mucositis . This randomized double blind clinical trial has been conducted on patients newly diagnosed of head and neck cancers. 40 patients with radiotherapy treatment plan with at least 40 Gray exposure doses to oral cavity according to the treatment protocol and age of 30-60 are selected and divided into two equal numbered groups of case and control. Each group of case and control are divided into two groups of male and female. Exclusion criteria are previous history of radiotherapy, hypersensitivity to mouthwashes, preexisting active oral diseases, any systemic diseases interfering with healing such as diabetes mellitus. From onset of radiotherapy, patients have given either placebo or 2% Sage mouthwashes, three times daily for 7 weeks. Each time patients hold 5 ml of mouthwash in oral cavity for 1 minute and then spit it out. The patients are examined once a week and oral mucositis intensity are measured by Oral Mucositis Assessment Scale (OMAS), which is based on the scores of erythema and ulcer in 9 areas of oral cavity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010410205N2
Registration date:2014-02-22, 1392/12/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-22, 1392/12/03
Registrant information
Name
Dariush Moslemi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1323 6752
Email address
d.moslemi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2014-02-04, 1392/11/15
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Sage (Salvia Officinalis) leaf hydroalcoholic Extract On Radation-Induced Oral Mucositis
Public title
Evaluation of Salvia Officinalis On Radiation-Induced Oral Mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1) Minimum accumulative dose of 40 Gy according to treatment protocol; 2) Complete exposure of oral cavity to radiation field ; 3) Minimum age of 30, maximum 60
Exclusion criteria : 1)Previous history of head and neck radiotherapy ; 2)Intolerance or hypersensitivity to the mouthwash; 3) Preexisting active oral disease; 4) Any systemic diseases interfering with wound healing
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Babol University of Medical Sciences
Street address
Babol, Ganjafrooz avenue
City
Babol
Postal code
Approval date
2013-02-05, 1391/11/17
Ethics committee reference number
2006
Health conditions studied
1
Description of health condition studied
Intensity of radiation induced oropharyngeal mucositis
ICD-10 code
K12.3
ICD-10 code description
Radiation induced mucositis (oropharyngeal)
Primary outcomes
1
Description
Intensity of oral mucositis
Timepoint
Once a week for 7 week
Method of measurement
Oral Mucositis Assessment Scale (OMAS)
Secondary outcomes
1
Description
Hypersesitivity to drug, patient intoerance
Timepoint
Once a week for7 weeks
Method of measurement
History and physical examination
Intervention groups
1
Description
Herbal extract of plant Salvia officinalis are added to a basic gel to make 2% Sage mouthwash. Patients are instructed to use the mouthwash 3 three times daily from onset of radiotherapy for 7 week duration, each time patients hold 5 ml of mouthwash in their oral cavity for 1 minute and then spitted it out.
Category
Prevention
2
Description
A gel which are equalized in taste, odor, shape and color to 2% Sage mouthwash are used as a placebo mouthwash. Patients are instructed to use the mouthwash 3 three times daily from onset of radiotherapy for 7 week duration. Each time patients hold 5 ml of mouthwash in their oral cavity for 1 minute.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy centre of Shahid Rajaie of Babolsar
Full name of responsible person
Dariush moslemi
Street address
Sahid Rajaie hospital, next to Shilat, Shariatie Str
City
Babolsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and Technology, Babol University of Medical Sciences
Full name of responsible person
Aliakbar moghadamnia
Street address
Babol University of Medical Sciences, Vice chancellor for research and Technology, ganj afrooz street, babol, mazandaran, iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and Technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Iman Gouran
Position
6th year Dentistry student
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Faculty of Dentistry, ganj afrooz street, babol, mazandaran, iran
City
Babol
Postal code
4717447745
Phone
+98 12 3222 0676
Fax
Email
imangouran@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dariush Moslemi
Position
Assistant professor of radiation oncology
Other areas of specialty/work
Street address
Devision of radiation oncology, Babol University of Medical Sciences, ganj afrooz street, babol, mazandaran, iran
City
Babol
Postal code
4717447745
Phone
+98 11 1222 4032
Fax
+98 11 1223 4367
Email
d.moslemi@mubabol.ac.irmoslemi_d@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Iman Gouran
Position
6th year student of Dentistry
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Faculty of denstitry, ganj afrooz street, babol, mazandaran, iran
City
Babol
Postal code
4717447745
Phone
+98 12 3222 0676
Fax
Email
imangouran@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)