The present study aims to compare the effectiveness of Alpha and hydrocortisone %1 ointment to prevent severe skin complications among patients with breast cancer. It is a double blind clinical study. 90 patients with advanced breast cancer under radiation therapy in Imam Reza hospital of Kermanshah city were selected randomly and divided into experiment groups. The first group used a thin layer of alpha ointment twice a day (a centimeter of ointment for 10*10 cm) on radiated area. The ointment is applied 2 hours after radiation and also 8 hours later. Notice that the area is cleaned using soap before radiation. The second group used hydrocortisone %1 ointment with the same dose and application. Then, variables of severe dermatitis resulting from radiation, pain, irritation and itch were investigated by physicians and through asking the patients at the beginning of the study and once a week to the end of the study in both groups. Inclusion criteria: written consent by patients; being treated by final mastectomy; at least three weeks after the last session of chemotherapy; having no burn, cut, infection and skin problems on radiation area. Exclusion criteria: having a history on collagen diseases, cases of diabetes through treatment; using systematic steroids; intolerance of radiation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052114333N34
Registration date:2015-07-20, 1394/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-20, 1394/04/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Alpha and hydrocortisone %1 ointment to prevent severe skin complications among patients with breast cancer
Public title
Effectiveness of Alpha and hydrocortisone %1 ointment to prevent severe skin complications among patients with breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: written consent by patients; being treated by final mastectomy; at least three weeks after the last session of chemotherapy; having no burn, cut, infection and skin problems on radiation area. Exclusion criteria: having a history on collagen diseases, cases of diabetes through treatment; using systematic steroids; intolerance of radiation.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly using sealed envelopes
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
kums.rec.1394.5
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
itching
Timepoint
Beginning of study, once a week and end of the study(6 to 7 weeks after beginning)
Method of measurement
Asking the patients
2
Description
irritation
Timepoint
Beginning of study, once a week and end of the study(6 to 7 weeks after beginning)
Method of measurement
Asking the patients
3
Description
Pain levels
Timepoint
Beginning of study, once a week and end of the study(6 to 7 weeks after beginning)
Method of measurement
Asking from the patients
4
Description
Severe skin complications
Timepoint
Beginning of study, once a week and end of the study(6 to 7 weeks after beginning)
Method of measurement
Based on observations and physician examination, RTOG according to the criterion
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the first group used a thin layer of alpha ointment produced by Alpha Tose company twice a day (a centimeter of ointment for 10*10 cm) on radiated area. The ointment is applied 2 hours after radiation and also 8 hours later he first application. Notice that the area is cleaned using soap before radiation.
Category
Treatment - Drugs
2
Description
The second group used a thin layer of hydrocortisone %1 ointment produced by Sina company twice a day (a centimeter of ointment for 10*10 cm) on radiated area. The ointment is applied 2 hours after radiation and also 8 hours later the first application. Notice that the area is cleaned using soap before radiation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza Hospital
Full name of responsible person
Ali Goli
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ahmad Khoshay
Position
Msc. of Surgical Internal Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9304
Fax
Email
Akhoshay@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)