Main objectives:Oral mucositis is one of the major side effects in cancer patients who has been radiotherapied. The aim of this clinical trial is to evaluate the efficacy of atorvastatin in prophylaxis of oral mucositis induced by radiotherapy. Design : Clinical trial , double blind , placebo controlled . Setting and Conduction : 50 patients ( 18-70 years old ) that can tolerate the radiotherapy will be recruited , In group 1 patients will take atorvastatin mouthwash , four times a day for a week ; in group 2 patients will take placebo mouthwash four times a day for a week . Participants : Inclusion criteria : patient who receive radiotherapy and age more than 18 years old ; Exclusion criteria : intolerance to atorvastatin mouthwash and incorrect use of it .Intervention: Atorvastatin mouth wash & placebo outcome measures variables: stomatitis, Solid & liquid dysphagia, hemorrhagia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502033014N9
Registration date:2015-06-04, 1394/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-04, 1394/03/14
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of atorvastatin mouthwash1% in prevention of radiotherapy induced oral mucositis on cancer patients in tehran city.
Public title
Evaluation of the efficacy of atorvastatin mouthwash 1% in prevention of radiotherapy induced oral mucositis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Cancer patients between 18-70 years receiving 5-fluorouracil containing chemotherapy regimens. Exclusion criteria: Sucralfate intolerance or inappropriate use of the mouth wash
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
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
Ethics Committee , Mazandaran University of Medical Sciences
Street address
Iran Vice chancellor for research , Moalem Square , Mazandaran University of Medical Sciences Sari Mazandaran , Islamic Republic Of
City
Sari
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
23
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.3
ICD-10 code description
موكوزيت دهاني ( زخم دهاني )
Primary outcomes
1
Description
Oral mucositis
Timepoint
Every 3 days
Method of measurement
Use of the WHO table and ruler
Secondary outcomes
1
Description
Pain
Timepoint
After 1 month of intervention
Method of measurement
Quastionnaire
Intervention groups
1
Description
Intervention 1 : ََAtorvastatin 1% mouthwas 5ml , 4 times a day for 4 week .
Category
Prevention
2
Description
Intervention 2 : placebo mouthwash, 5ml, 4 times a day for 4 week .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer institute, Imam Khomeini hospital ,Tehran
Full name of responsible person
Zahra Jahangard
Street address
Keshavarz BLVD
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Vice chancellor of research,Moalem squer, Mazandaran, Sari, Mazandaran University of Medical SciencesMazandaran University of Medical SciencesMazandaran University of Medical Sciences Sari Mazandaran Iran, Islamic Republic Of 00981513543083
City
Sari
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, Mazandaran 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
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Melika Namdari
Position
Pharmacy student
Other areas of specialty/work
Street address
Faculty of Pharmacy, 400 Hectari, Jadeh darya, Sari Mazandaran Iran