Topical Erythropoietin Effectiveness for prophylaxis of radiation induced dermatitis in breast cancer patients refer to Ramazan Zadeh radiotherapy center of Yazd
Design
A total of 50 female patients older than 18 years with positive histology confirmed the diagnosis of invasive and localized breast cancer, who are candidates for adjuvant radiotherapy after surgery (breast conservation surgery or mastectomy). Patients will be randomized according to a table of random numbers. The study is three-blind and the duration of using the cream is from the first day of radiotherapy to the last day of radiation.
Settings and conduct
This study is a three-blind study that will be performed at Shahid Ramezanzadeh Radiation Therapy Center in Yazd. Patients, Radiation oncologist and evaluator of the outcome of the intervention will be blinded. Using the cream is from the first day of radiation therapy to the last day of radiation therapy twice daily.
Participants/Inclusion and exclusion criteria
A total of 50 female patients older than 18 years with positive histology confirmed the diagnosis of invasive and localized breast cancer, who are candidates for adjuvant radiotherapy after surgery (breast conservation surgery or mastectomy).
Intervention groups
Intervention group: receiving 0.168% Erythropoietin cream
Control group: receiving placebo
Topical Erythropoietin Effectiveness for prophylaxis of radiation induced dermatitis in breast cancer patients
Public title
Topical Erythropoietin Effectiveness for prophylaxis of radiation induced dermatitis in breast cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients older than 18 years
patients with positive histology confirm invasive and localized breast cancer
Patients who candidates for adjuvant radiotherapy after surgery (breast conserving or mastectomy)
Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects
Exclusion criteria:
Inflammatory or metastatic carcinoma
Extensive skin diseases
Connective tissue diseases
known sensitivity to drug
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In order to select the sample people from the table of the random numbers, the researcher randomly starts from a point of the table in the direction of the row or column. Researcher can close her eyes and choose a point. Then based on whether the number is even or odd, the patient is given medicine A or B.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After the cream preparement , the labels A and B are affixed by a third person and the patients, Radiation oncologist and evaluator of this outcome will be blinded to the type of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's Committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of medical Sciences, Shohadaye Gomnam Blvd, Allem square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2023-07-16, 1402/04/25
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.135
Health conditions studied
1
Description of health condition studied
Radiodermatitis
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Acute radiation dermatitis
Timepoint
Weekly during radiotherapy and two weeks after the end of radiotherapy
Method of measurement
Based on the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG / EORTC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical Erythropoietin cream is made by the operator in the laboratory. Patients with breast cancer referred to the center Radiation therapy is included in the study. Patients apply the cream twice a day from the first day of radiotherapy to the last day on the radiation receiving area and after two hours the area is washed. In case of grade 2 dermatitis, the drug is discontinued and the patient undergoes routine treatments. but remains in the study until the end of treatment for follow-up.
Category
Prevention
2
Description
Control group: Placebo cream is made by the operator in the laboratory. Patients with breast cancer referred to the center Radiation therapy is included in the study. Patients apply the cream twice a day from the first day of radiotherapy to the last day on the radiation receiving area and after two hours the area is washed. In case of grade 3 dermatitis, the drug is discontinued and the patient undergoes routine treatments. but remains in the study until the end of treatment for follow-up.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ramezanzadeh Radiation Therapy Center
Full name of responsible person
Dr. Massoud Shabani
Street address
Shahid Motahari Street
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۶۵۷۹۶۱
Phone
+98 35 3725 1174
Fax
+98 35 3724 4078
Email
partodarmani@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Ave, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Fax
+98 35 3725 4750
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Seyede Sahar Mesbah
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 6 Lale Alley, Abouzar Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3419
Email
sahar_mesbah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Saghafi
Position
Professor assistant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Allem Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3725 1174
Email
f.saghafi@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyede Sahar Mesbah
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Allem Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3826 3448
Email
Sahar_mesbah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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