Sixty patients with breast cancer at Babolsar's Shahid-Rajaee hospital, with indication of radiotherapy after modified radical mastectomy, would be allocated in 2 groups (control and test). Patients with diabetes mellitus, collagen vascular, concurrent chemotherapy, or history of chest wall radiation would be excluded from the study. Patients would be randomly allocated in each 2 groups and would receive either Recove 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 according the RTOG (Radiation Therapy Oncology Group) criteria by a radiation oncologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204047136N2
Registration date:2013-01-27, 1391/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-27, 1391/11/08
Registrant information
Name
Ebrahim Zabihi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4650
Email address
e.zabihi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and technology-Babol University of Medical Sciences-
Expected recruitment start date
2012-08-05, 1391/05/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic and therapeutic effects of Recove Ointment on radiation induced dermatitis in breast cancer patients
Public title
Prophylactic and therapeutic effects of Recove Ointment on radiation induced dermatitis in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having diagnosed as having breast cancer; indication of radiotherapy and already underwent modified radical mastectomy.
Exclusion criteria: Diabetes mellitus; Collagen vascular diseases; concurrent chemotherapy and history of chest wall radiation therapy.
Age
No age limit
Gender
Female
Phase
2
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
Babol University of Medical Sciences
Street address
Ganje-Afrouz St.
City
Babol
Postal code
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
6830/30/ژ/پ
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 reaction
Timepoint
weekly
Method of measurement
physical exam
Intervention groups
1
Description
Intervention (Recove(R) topical ointment): Patients undergoing radiotherapy will receive Recove 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
City
Babolsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology- Babol University of Medical Scenices
Full name of responsible person
Dr Ali Bijani
Street address
Research and Development office
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of 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
Research and technology affair - Babol University of Medical Sciences
Full name of responsible person
Ebrahim Zabihi
Position
Lecturer, Academic staff
Other areas of specialty/work
Street address
Ganje afrooz Avenue,Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1219 9596
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 Ebrahim Zabihi
Position
PharmD, PhD, Pharmacology
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Department of Pharmacology and physiology
City
Babol
Postal code
Phone
+98 11122199596
Fax
Email
e_zabihi@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
Ganj-Afrouz St.
City
Babol
Postal code
Phone
+98 11121995916
Fax
+98 11 1323 6510
Email
e.zabihi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)