Forty patients who are referred to the Imam-Reza hospital affiliated to Mashhad University of Medical Sciences with breast cancer diagnosis according to the histopathology results, with age above 18 years old that underwent mastectomy are included in study. These patients will receive radiotherapy with or without coverage of axillary lymph nodes. The tridimensional therapy plan is used to take total dose of 50.4 Gy (1.8 Gy daily during the course 5.5 weeks). Boost dose 16.9 Gy is radiated to the initial involvement area. Patients randomly are included in silymarin or placebo group and will receive formulation in the chest area under radiotherapy twice daily (about 1g) from the first day of radiotherapy (two hours before the first radiotherapy session) until the end of the treatment course. Patients in both groups are evaluated at the beginning and during radiotherapy, at weekly intervals, in terms of the radiodermatitis occurrence according to the criteria of RTOG and NIH CTCAE version 4.03. Moreover, at weekly intervals, patients will be interviewed regarding possible adverse reactions or new prescribed or OTC medications. It should be noted that the administrators (oncology specialists) are unaware of the type of prescription drug (placebo-drug) and are prepared and numbered by a clinical pharmacist and placebo in similar forms..
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110730760N1
Registration date:2017-11-01, 1396/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Hediyeh Karbasforooshan
Name of organization / entity
Faculty of pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 51 3866 3516
Email address
karbasfh911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical sylimarin formulation efficacy in prevention of radiodermatitis in breast cancer patients
Public title
Evaluation of topical sylimarin formulation efficacy in prevention of radiotherapy induced skin reactions in breast cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age above 18 years; Breast cancer patients after mastectomy undergoing radiotherapy; X-ray total dose of 50.4 GY
Exclusion criteria: Diabetes; Smoking; Anti inflammatory drugs; Immunosuppressor drugs; Immunodeficiency diseases; Connective tissue diseases
Age
From 18 years old to 70 years old
Gender
Female
Phase
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Central organization of Mashhad University of Medical Sciences, Daneshgah Ave.
City
Mashhad
Postal code
1394491388
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR.MUMS.REC.1395.27
Health conditions studied
1
Description of health condition studied
Radiodermatitis
ICD-10 code
L58.9
ICD-10 code description
Radiodermatitis, unspecified
Primary outcomes
1
Description
radiodermatitis occurrence
Timepoint
1 week after intervention,2week after intervention,3week after intervention,4week after intervention,5week afterintervention
Method of measurement
NCI CTCAE version 4.03 and Acute Radiation Morbidity Scoring Criteria (RTOG)
Secondary outcomes
empty
Intervention groups
1
Description
Silymarin ointment produced by Goldaru Company, twice daily on breasts, for 5.5 weeks after radiotherapy
Category
Treatment - Drugs
2
Description
Placebo ointment produced by Goldaru Company, twice daily on breasts, for 5.5 weeks after radiotherapy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Sare Hosseini
Street address
Imam Reza Sq.,Imam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakil Abad Blv.- School of Pharmacy
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hedyieh Karbasforooshan
Position
Pharm.D student
Other areas of specialty/work
Street address
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
9415945344
Phone
+98 51 3180 1588
Fax
+98 51 3882 3251
Email
karbasfh911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Ph.D
Other areas of specialty/work
Street address
School of Pharmacy, Ferdowsi University Campus, Vakil Abad Blvd.
City
Mashhad
Postal code
9415945344
Phone
+98 51 3180 1588
Fax
+98 51 3882 3251
Email
elyasis@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hedyieh Karbasforooshan
Position
Pharm.D student
Other areas of specialty/work
Street address
School of Pharmacy, Ferdowsi University Campus, Vakil Abad Blvd.
City
Mashhad
Postal code
9415945344
Phone
+98 51 3180 1588
Fax
+98 51 3882 3251
Email
karbasfh911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)