The study of radioprotective effects of topical atorvastatin gel on skin toxicity in breast cancer radiotehrapy: a double-blind randomized, placebo- controlled clinical trial
The aim of this study is to evaluate the radioprotective effect of atorvastatin topical drug on acute radiation dermatitis induced by ionizing radiation in patients with breast cancer. This study is a double blind randomized, placebo-controlled clinical trial. This study will be performed on sixty patients with breast cancers that will admit to Radiotherapy Center in Imam Khomeini Hospital in Sari, Iran. Inclusion criteria are patients with breast cancer after surgery with ages 18-60 years old. Exclusion criteria are patients with liver, kidney injuries and with acute dermatitis and take anti-inflammatory and corticosteroids drugs. Patients will receive atorvastatin topical drug or placebo two times per day (BD) during radiotherapy fractions. Drug or placebo administration will be continued end of radiotherapy in patients. Severity of skin side effects will be visited and recorded in questioners' forms according to RTOG criteria during this study weekly, these parameters are dermatitis, etyma, wound, scare, pain and inching. The results of atorvastatin and placebo groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062219423N2
Registration date:2016-07-20, 1395/04/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-20, 1395/04/30
Registrant information
Name
Seyed Jalal Hosseinimehr
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 4308
Email address
sjhosseinim@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of radioprotective effects of topical atorvastatin gel on skin toxicity in breast cancer radiotehrapy: a double-blind randomized, placebo- controlled clinical trial
Public title
The study of radioprotective effects of topical atorvastatin gel on skin toxicity in breast cancer radiotehrapy: a double-blind randomized, placebo- controlled clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Adults over 18 years and less 70 years; breast cancer; about 50Gy total dose of radiation.
Exclusion criteria: Smoking; sing the anti-inflammatory drug such as dexametasone and NSAID; active skin infection and dermatitis; using any topical products on breast; the disease weakens related to the immune system and a lack of diabetes that affected on wound healing; diseases related to kidney and liver.
Age
From 18 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethical Committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Mazandaranl University of Medical Scenices, Molam Sq
City
Sari
Postal code
Approval date
2016-06-05, 1395/03/16
Ethics committee reference number
IR.MAZUMS.REC.95-2159
Health conditions studied
1
Description of health condition studied
Radiodermatitis
ICD-10 code
C50, L58
ICD-10 code description
Malignant neoplasm of breast, Acute radiodermatitis
Primary outcomes
1
Description
Severity of radiation-induced skin toxicity (such as Erythema, dry desquamation, itching, and ulcer)
Timepoint
Just before drug treatment and then weekly for end of radiotehrapy
Method of measurement
According to RTOG scoring system with a questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Patients undergoing radiotherapy will receive topical atorvastatin containing BD. Gel toically will be administrated on skin of breast.
Category
Treatment - Drugs
2
Description
Patients undergoing radiotherapy will receive placebo topica. Gel toically will be administrated on skin of breast. l
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy Center, Imam Hospital
Full name of responsible person
Dr Arash Ghasemi
Street address
Radiotherapy Center, Imam Hospital, Mazandaran University of Medical
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Mazandaranl University of Medical Scenices
Full name of responsible person
Ahmad Ali Enayati
Street address
Mazandaran University of Medical Sciences, Moalem Sq
City
Sari
Grant name
Grant code / Reference number
2159
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Mazandaranl University of Medical Scenices
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
Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Jalal Hosseinimehr
Position
Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, 17 Km Sea road