Evaluation of grape seed extract on oral mucositis inpatients with head and neck radiotherapy history
Design
A randomized, double blinded, clinical trial with 50 patients in two group, 25 patients are intervention group and 25 patients are control group. Patients in the beginning day of radiotherapy received mouthwash with special code and followed for two weeks.
Settings and conduct
The patients in the Radiotherapy-Oncology Center of Shahid Madani hospital were recognized and in beginning of treatment they received a mouthwash with special code.Mouthwashes were two groups, one group is grape seed extract mouthwash and another group is placebo which were been coded by producer and patient and researcher didn`t aware about the type of mouthwash.The patients were followed for two weeks and were examined in the first-5th-10th-14th days and the information was recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1-Complete consciousness
2-Ability of reading and writing
3-Oral mucus healthy
4-Total radiation more than 60 Gray in radiotherapy duration and 2 Gray radiation everyday
Exclusion criteria
1-Respiratory system diseases and asthma
2-Diabetes
3-Autoimmune diseases
4-Fever and Neutropenia
5-Continuous usage of analgesics
6-Narcotic drug usage
7-Antibiotics usage
8-Using another mouthwash during investigation
9-Chemotherapy
Intervention groups
Patients receive 2% grape seed extract mouthwash in beginning day of radiotherapy to use for 2 weeks.Patients use mouthwash everyday 3 times and each time for 3 minutes.We examine the patients in first-5th-10th-14th days and record the observations.
In control group we use placebo instead of mouthwash and patients use it for 2 weeks in the same way and we visit them and record the observations.
Main outcome variables
1-Mucositis intensity
2-Mucositis evaluation in first-5th-10th-14th days
3-Mucositis grading
General information
Reason for update
Acronym
G.S.E
IRCT registration information
IRCT registration number:IRCT20181022041418N1
Registration date:2019-06-03, 1398/03/13
Registration timing:retrospective
Last update:2019-06-03, 1398/03/13
Update count:0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
Javad Ahmadiadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 3311
Email address
ahmadiadeh90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-11, 1398/01/22
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adjunctive effect grape seed extract(GSE) on oral mucositis in patients with a history of head and neck radiotherapy
Public title
Evaluation of grape seed extract effect on oral mucositis in patients with a history of head and neck radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complete consciousness
Ability of reading and writing
Oral mucus healthy
Total radiation more than 60gray in radiotherapy duration and 2gray radiation everyday
Exclusion criteria:
Respiratory system diseases and asthma
Diabetes
Autoimmune diseases
Fever and Neutropenia
Continuous usage of analgesics
Narcotic drug usage
Antibiotics usage
Using another mouthwash during investigation
Chemotherapy during investigation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
At first 50 patients that have investigation standards are identified.Two types of mouthwash are prepared; type 1 is grape seed extract mouthwash(25 bottles) and type 2 is placebo(25 bottles).Both patient and researcher doesn,t aware that use which type of mouthwash; only the producer of mouthwash can recognize the type of mouthwash with special codes.
In the first day of radiotherapy each patient randomizely receive a bottle of mouthwash to use for two weeks.
finally in the group study we have 50 patients that 25 of them have received grape seed extract mouth wash(intervention group) and 25 patients have received placebo(control group).
Blinding (investigator's opinion)
Double blinded
Blinding description
Two types of mouthwashes are being prepared; type 1 is grape seed extract mouthwash and type 2 is placebo.Both patient and researcher don;t aware about the type of mouthwash; only the producer can recognize the type of mouthwash by special codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Univercity of Medical Sciences
Street address
Research-vice third floor,No 2 medical sciences Building Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.TBZMED.REC.1397.515
Health conditions studied
1
Description of health condition studied
Post Radiation Mucositis
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
Mucositis intensity
Timepoint
First-5th-10th-14th days after mouthwash using
Method of measurement
Mucositis grading 0-4
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:25 patients whom will be treated under head and neck radiotherapy are being recognized and they receive 2% grape seed extract mouth wash which has been produced by Tabriz Drug Applied Center, patients use mouthwash everyday 3 times and each time for 3 minutes during 2 weeks.Patients are being examined in first-5th-10th-14th days and we record the observations.
Category
Treatment - Drugs
2
Description
Control group:25 patients whom will be treated under head and neck radiotherapy are being recognized and they receive placebo which has been produced by Tabriz Drug Applied Center. Patients use placebo everyday during radiotherapy 3 times and each time for 3 minutes.Patients use placebo for 2 weeks and be examined in first-5th-10th-14th days and observations be recorded.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Shahid Madani radiation-oncology center
Full name of responsible person
Dr.Amir Ghasemi Jangjo
Street address
Radiotherapy and Oncology part, Shahid Madani Hospital Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7767
Fax
+98 41 3335 7767
Email
afsaris@tbzmed.ac.ir
Web page address
http://madanihosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hossein Babaei
Street address
Drug Applied Research Center, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 3311
Email
babaei42@yahoo.com
Web page address
http://darc.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hossein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental facualty,Golgasht Ave,Azadi Blvd
City
Tariz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41333559659
Email
eslamihosein56@yahoo.com
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hossein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41333559659
Email
eslamihosein56@yahoo.com
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Ahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty,Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41333559659
Email
ahmadiadeh90@gmail.com
Web page address
http://dentistryfac.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
We share only the mucositis changes after using mouthwash.
When the data will become available and for how long
Data will be accessible one year after printing of the results.
To whom data/document is available
Both researchers and mouthwash producer companies can access the documents.
Under which criteria data/document could be used
In similar studies in patients with history of head and neck radiotherapy by changing the concentration of mouthwash and longer follow up it is possible.Also it is possible for evaluation the other effects of grape seed extract.
From where data/document is obtainable
1-Dr.Hosein Babaei Drug Applied Research Center Golgasht Ave,Tabriz
Tel:04133363311 Email:babaei42@yahoo.com
2-Dr.Javad Ahmadi Dentistry faculty Golgasht Ave, Tabriz Tel:09144476091 Email:ahmadiadeh90@gmail.com
What processes are involved for a request to access data/document
At first the applicant send her/his requisition to one of respondents and after surveying and confirmation of identity and ask about the intentions, the documents are available for him.