Comparison of the efficacy of topical Mometasone 0.1% and topical Hydrocortisone 1% and placebo in the prevention of acute radiation dermatitis in breast cancer patients
Comparison of the efficacy of topical Mometasone 0.1% and topical Hydrocortisone 1% and placebo in the prevention of acute radiation dermatitis in breast cancer patients
Design
The study is a three arm parallel group phase 3 prospective clinical randomized trial with plasebo control and is triple blinded. Random allocation is simple and carried out with statistical software SPSS 22.
Settings and conduct
Sampling is simple and patients are selected from breast cancer patients who come for adjuvant radiation treatment to Omid hospital in Esfahan. One check list is filled for each patient about her information and disease and radiation treatment protocol. Persons who prescribe the treatment and assess and analysis the data as well as patients will be blind to the drug. All explanation about who to use drugs will be given to the patients verbally and with brochures. If radiation dermatitis occur, the grade is determined according to CTCEA(V4) scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with breast cancer who had surgery and should undergo breast radiation as adjuvant treatment;
Exclusion criteria: Past history of skin disease like eczema and psoriasis, past history of connective tissue disease like lupus erythematosus and sclerodermia, recurrent or metastatic breast cancer, past radiation to the skin of treatment field.
Intervention groups
Intervention group: Mometasone 0.1% cream; Hydrocortisone 1% cream
Control group: placebo which is base cream of interventional creams
Main outcome variables
radiation dermatitis grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180222038825N1
Registration date:2018-03-28, 1397/01/08
Registration timing:registered_while_recruiting
Last update:2018-03-28, 1397/01/08
Update count:0
Registration date
2018-03-28, 1397/01/08
Registrant information
Name
Mahsa Kianinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 8005
Email address
mahsa.kianinia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of topical Mometasone 0.1% and topical Hydrocortisone 1% and placebo in the prevention of acute radiation dermatitis in breast cancer patients
Public title
The effect of topical Mometasone 0.1% and topical Hydrocortisone 1% in the prevention of acute radiation dermatitis of breast
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast cancer who had breast conservative surgery and should undergo breast radiation as adjuvant treatment
Exclusion criteria:
Past history of skin disease like eczema and psoriasis
Past history of connective tissue disease like lupus erythematosus and sclerodermia
recurrent or metastatic breast cancer
Past radiation to the skin of treatment field
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
randomization is simple and this will be done with statistical software SPSS 22.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Persons who prescribe the treatment and asses the results and also the patients are blind to the given drug; so some one else will put the drugs in the packets according the random allocation list.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IR.MUI.REC.1396.3.111
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
Radiation dermatitis grade
Timepoint
weekly after initiation of radiotherapy until the end of whole breast radiation
Method of measurement
Common Terminology Criteria for Adverse Events v4.0 (CTCAE) scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Topical cream Mometasone 0.1%. The cream should be used once a day which is used after radiation. Also Patients will be instructed to wash skin with baby shampoo before radiation and no any cream should be on the skin. On Thursdays and Fridays that radiation will not be done, patients should use the cream on the skin once a day. This cream is manufactured by Behvazan pharmaceutics company in Iran.
Category
Treatment - Drugs
2
Description
Intervention group 2: Topical cream Hydrocortisone 1%. The cream should be used once a day which is used after radiation. Also Patients will be instructed to wash skin with baby shampoo before radiation and no any cream should be on the skin. On Thursdays and Fridays that radiation will not be done, patients should use the cream on the skin once a day. This cream is manufactured by Emad Darman Pars pharmaceutics company in Iran.
Category
Treatment - Drugs
3
Description
Control group: Base cream. The cream should be used once daily which is after radiation is done. Also Patients will be instructed to wash skin with baby shampoo before radiation and no cream should exist on the skin. On Thursdays and Fridays that radiation will not done, patients should use the cream once daily on the skin. This cream is manufactured in D.r Shahtalebi Lab in Iran.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Mahsa Kianinia
Street address
Omid hospital, Motahari St, Khayam St.
City
Esfahan
Province
Isfehan
Postal code
8184917395
Phone
+98 31 3235 0210
Fax
+98 31 3236 3224
Email
mahsa.kianinia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Roayaei
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
roayaei@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Kianinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Khayam St, Matahari St
City
Esfahan
Province
Isfehan
Postal code
8184917395
Phone
+98 31 3235 0210
Email
mahsa.kianinia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Roayaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Khayam St, Motahary St
City
Esfahan
Province
Isfehan
Postal code
8184917395
Phone
+98 31 3235 0210
Email
roayaei@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Kianinia
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Khayam St, Motahary St
City
Esfahan
Province
Isfehan
Postal code
8184917395
Phone
+98 31 3235 0210
Email
mahsa.kianinia@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD