Skin toxicity is a common side effect induced by ionizing radiation in patients during radiotherapy of breast cancer. Celecoxib (CLX) is a COX II inhibitor that widely is used by human for anti-inflammation. In this study we will investigate the protective effect of CLX on acute radiation dermatitis induced by ionizing radiation in patients with breast cancer. This study is a double blind randomized, placebo-controlled clinical trial. Patients will randomize in two groups of case and placebo. Patients will receive oral capsule of placebo or CLX at dose 200 mg bid during radiotherapy. Severity of skin side effects will be visited and recorded according to RTOG criteria during this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100619423N1
Registration date:2015-01-20, 1393/10/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-20, 1393/10/30
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
2015-04-09, 1394/01/20
Expected recruitment end date
2016-07-01, 1395/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radioprotective effects of celecoxib on skin toxicity caused by radiotherapy in patients with breast cancer
Public title
The evaluation of celecoxib against skin toxicity caused by radiotherapy in patients with breast cancer
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 70 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
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
1276
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 celecoxib capsules containing BD.
Category
Treatment - Drugs
2
Description
Patients undergoing radiotherapy will receive placebo capsules containing lactose,BD.
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
1276
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
Seyed Jalal Hosseinimehr
Position
Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, 17 Km Sea road