Evaluation of 2% curcumin gel effevtiveness in prophylaxis of radiation dermatitis
Design
Placebo-controlled double-blind clinical trial with parallel groups of 52 patients
Settings and conduct
The study was conducted at the Shahid Ramezanzadeh Radiation Therapy Center in Yazd. A total of 60 female patients with breast cancer who were considered to be the initiators of radiation therapy were randomly selected and entered one of the two study groups rather than one of the drug groups. (Corkumine gel should be 2% and placebo gel). The patient evaluating the outcome and the clinical caregivers were unaware of the type of drug. The patients used the gel twice a day for four weeks from the first day of radiation therapy. Information on the severity of rubella, the severity of pruritus, the severity of the burn, and the severity of the pain were recorded at the opposite time (beginning of treatment in the first week, second week, third week, and fourth week after treatment).
Participants/Inclusion and exclusion criteria
Women 18 to 65 years old to get started Breast radiation therapy has been referred to Shahid Ramezanzadeh Radiotherapy Center in Yazd
Intervention groups
Intervention group: Patients receiving 2% curcumin gel. Control group: Patients receiving placebo gel
Main outcome variables
Curcumin gel 2% was able to reduce the severity of burning and pain in patients compared to placebo gel, but there was no difference between the curcumin and placebo groups in terms of itching severity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N3
Registration date:2020-11-06, 1399/08/16
Registration timing:retrospective
Last update:2020-11-06, 1399/08/16
Update count:0
Registration date
2020-11-06, 1399/08/16
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-16, 1398/03/26
Expected recruitment end date
2019-10-27, 1398/08/05
Actual recruitment start date
2019-06-15, 1398/03/25
Actual recruitment end date
2019-11-16, 1398/08/25
Trial completion date
2019-11-16, 1398/08/25
Scientific title
Evaluation of 2% curcumin gel effevtiveness in prophylaxis of radiation dermatitis
Public title
Evaluation of curcumin gel effevtiveness in prophylaxis of radiation dermatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18 to 65 years old to get started breast radiation therapy has been referred to Shahid Ramezanzadeh Radiotherapy Center in Yazd
Exclusion criteria:
People with skin diseases
People who are allergic to curcumin
People with severe systemic diseases such as uncontrolled diabetes
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method was used. Patients were randomly assigned to two groups by using Random.org site
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, clinical caregivers and outcome assessors were unaware of the type of medication patients were receiving. Patients in both groups received the medication in the same package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd university of medical sciences
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blve Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-02-06, 1397/11/17
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.078
Health conditions studied
1
Description of health condition studied
Dermatitis caused by breast radiation therapy
ICD-10 code
L58
ICD-10 code description
Radiodermatitis
Primary outcomes
1
Description
Intensity of redness
Timepoint
The severity of the redness begins with treatment Redness intensity in the first week Redness intensity in the second week Redness intensity in the third week and redness intensity in the fourth week after starting treatment
Method of measurement
RTOG standard scale
2
Description
Itching intensity
Timepoint
The severity of itching begins treatment Severity of itching in the first week Severity of itching in the second week Severity of itching in the third week and severity of itching in the fourth week after starting treatment
Method of measurement
Based on a question from the patient
3
Description
Intensity of burning
Timepoint
Severe onset of burning of treatment of severity of burning in the first week, severity of burning in the second week, severity of burning in the third week, and severity of burning in the fourth week after starting treatment
Method of measurement
Based on a question from the patient
4
Description
Intensity of pain
Timepoint
Intensity of pain Initiation of treatment Intensity of pain The first week Pain intensity in the second week Pain intensity in the third week and pain intensity in the fourth week after starting treatment
Method of measurement
Based on a question from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Curcumin gel 2% twice daily from the first day Radiation therapy The patient receives one of the same gels topically for four weeks. Made in Yazd University of Medical Sciences
Category
Prevention
2
Description
Control group: Placebo gel twice daily from the first day Radiation therapy The patient receives one of the same gels topically for four weeks. Made in Yazd University of Medical Sciences
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ramezanzadeh Radiotherapy Center, Yazd
Full name of responsible person
Masood Shabani
Street address
Yazd Azadi Sq Shahid Mottahari Street
City
Yazd
Province
Yazd
Postal code
8917657961
Phone
+98 35 3725 1171
Email
shabanimasood@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnan Blvd Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشگاه علوم پزشکی یزد
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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blv Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blvd Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3830 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistent professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blvd Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Dr.Behrooz Heydari email :b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your informationby email :The data will be sent after a week