Objectives: Phenytoin has been known to be effective in wound healing processes. In this clinical trial we aim to evaluate its efficacy in radiotherapy induced dermatitis.
Deign: Fifty female patients with breast cancer at Babolsar's Shahid-Rajaee hospital, with indication of radiotherapy after modified radical mastectomy (Inclusion criteria), would be allocated in 2 groups (control and test).
Setting and conduct: Patients with diabetes mellitus, collagen vascular, concurrent chemotherapy, or history of chest wall radiation would be excluded from the study (Exclusion criteria). Patients would be randomly allocated in each 2 groups and would receive either phenytoin 1% or ointment base (petrolatum). The ointments would be applied on the chest wall (region of radiotherapy) 2 times daily. The target area would be washed with a neutral soap (Dove (R)) every time before radiation therapy. The radiotherapy induced acute dermatitis would be scored weekly according to RTOG (Radiation Therapy Oncology Group) criteria by a radiation oncologist (Main Outcome measures).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070710205N1
Registration date:2013-06-01, 1392/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-01, 1392/03/11
Registrant information
Name
Dariush Moslemi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1323 6752
Email address
d.moslemi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Babol University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic & therapeutic effects of topical phenytoin administration on radiation induced dermatitis in breast cancer patients
Public title
Phenytoin application in radiation induced dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with first occurrence of breast cancer
Exclusion criteria: Patients with concurrent chemoradiation; diabetes; collagen-vascular diseases; history of radiotherapy
Age
From 16 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Babol University of Medical Sciences' Ethics Committee
Street address
Ganje-Afrouz St.
City
Babol
Postal code
4717641367
Approval date
2012-09-09, 1391/06/19
Ethics committee reference number
پ/ژ/30/ 7074
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.0
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Dermatitis
Timepoint
Weekly
Method of measurement
According to RTOG scoring system
Secondary outcomes
1
Description
Local adverse reactions
Timepoint
weekly
Method of measurement
physical exam
Intervention groups
1
Description
Intervention (Phenytoin topical ointment): Patients undergoing radiotherapy will receive Phenytoin ointment BD, for 25 sessions (5 days/week)
Category
Treatment - Drugs
2
Description
Control (Placebo/ ointment base): Patients undergoing radiotherapy will receive petrolatum ointment BD, for 25 sessions (5 days/week)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babolsar-Shahid Rajaee Hospital
Full name of responsible person
Dr Dariush Moslemi
Street address
Shariatee St,
City
Babolsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Scenices
Full name of responsible person
Dr Ali Bijani
Street address
Vice Chancellor for Research and Technology; Babol University of Medical Sciences; Ganje-Afrooz St.
City
Babol
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 and Technology, Babol 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
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Full name of responsible person
Ebrahim Zabihi
Position
Lecturer, Academic staff
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganje afrooz Avenue, Babol
City
Babol
Postal code
Phone
+98 11121995915
Fax
Email
e_zabihi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Dariush Moslemi
Position
Lecturer/Assistant professor
Other areas of specialty/work
Street address
Department of Radiation Oncology, Babol University of Medical Sciences,
City
Babol,
Postal code
Phone
+98 11 1223 4143
Fax
Email
moslemi_d@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol Universality of Medical Sciences
Full name of responsible person
Dr Ebrahim Zabihi
Position
Lecturer/Assistant professor
Other areas of specialty/work
Street address
Babol Universality of Medical Sciences, Ganje-Afrooz St.,
City
Babol,
Postal code
Phone
+98 11121995915
Fax
Email
e.zabihi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)