Prevention and reduction of severity of Radiation induced dermatitis in patients with breast cancer
Design
Randomize double blind clinical trial with two parallel control and experimental arm
Sample size: 50
Settings and conduct
Patients will be divided into two groups randomly in IMAM HOSSEIN hospital. From the beginning of radiotherapy patients will use cream locally in the area under radiation, two times daily, once after treatment and once before bedtime . Patients will be evaluated weekly for complications, and the way of using of the cream. If dermatitis occurs, its grade will be recorded. Radiation dermatitis is graded based on RTOG International Scoring System. Patients, researcher and dermatitis evaluator will be blinded.
Participants/Inclusion and exclusion criteria
Patients with breast cancer who had breast conservative surgery include in this study.
Exclusion criteria :
Radical mastectomy; Skin involvement; Diabetes; Renal failure; History of hypersensitivity to henna ; Smoking; Skin diseases; History of chest wall irradiation; Concurrent chemotherapy
Intervention groups
Patients with breast cancer who had the indication of radiotherapy are divided into two groups.
From the beginning of radiotherapy, natural henna cream is prescribed to experimental group and placebo is prescribed to control group and patients use them in the area under radiation two times daily.
Main outcome variables
Grade of dermatitis; Time of incidence of dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191107045357N1
Registration date:2020-05-07, 1399/02/18
Registration timing:registered_while_recruiting
Last update:2020-05-07, 1399/02/18
Update count:0
Registration date
2020-05-07, 1399/02/18
Registrant information
Name
Mansour Lesan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 2610
Email address
mansourlesan@mail.sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-16, 1398/08/25
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Henna cream ( Lawsonia inermis L) in preventing and reducing the severity of Radiation induced dermatitis in patients with breast cancer
Public title
The efficacy of Henna cream in preventing of Radiation induced dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast cancer who had breast conservative surgery
Exclusion criteria:
Collagen vascular diseases
Skin diseases
Hypersensitivity to Henna
Smoking
Diabetes mellitus
Chronic renal failure
Concurrent chemotherapy
History of chest wall irradiation
History of severe reaction to topical medication
Inflammatory breast cancer
Radical mastectomy
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, Researcher, Outcome evaluator
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences; Yaman Street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-14, 1398/02/24
Ethics committee reference number
IR.SBMU.MSP.REC.1398.131
Health conditions studied
1
Description of health condition studied
Radiation induced dermatitis
ICD-10 code
L58.0
ICD-10 code description
Acute radiodermatitis
Primary outcomes
1
Description
Grade of dermatitis
Timepoint
Weekly during radiotherapy
Method of measurement
RTOG Grading Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cream contains 10% henna: From the beginning day of radiotherapy, patients will apply a thin layer of the cream topically to the irradiated areas, twice a day, once after treatment, and once before bedtime.
Category
Treatment - Drugs
2
Description
Control group: Placebo: Cream without pharmaceutical substance: From the beginning day of radiotherapy, patients will apply a thin layer of the cream topically to the irradiated areas, twice a day, once after treatment, and once before bedtime.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mansour Lesan
Street address
Radiotherapy oncology Department of Imam Hossein hospital; Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2610
Email
mansourlesan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences; Yaman Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mansour Lesan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Radiotherapy oncology Department of Imam Hossein hospital; Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009873432610
Email
mansourlesan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mansour Lesan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Radiotherapy oncology Department of Imam Hossein hospital; Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2610
Fax
Email
mansourlesan@mail.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mansour Lesan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Radiotherapy oncology Department of Imam Hossein hospital; Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2610
Fax
Email
mansourlesan@mail.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Personal data including demographic data and main outcome results, study protocol, data statistical analysis, Informed consent form , study report
When the data will become available and for how long
Three mounts after publishing results
To whom data/document is available
Everyone with permission
Under which criteria data/document could be used
For further researches
From where data/document is obtainable
mansour.stan@gmail.com
Mansour Lesan
What processes are involved for a request to access data/document