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Comparison of the effect of 5% minoxidil and topical epinephrine on the prevention of chemotherapy-induced hair loss in patients with breast cancer compared to the control group (placebo recipients)

Protocol summary

Study aim
Determination of the effect of 5% minoxidil and topical epinephrine solution on the interval between chemotherapy-induced hair loss hair regrowth, duration of hair loss, and prevention of hair loss Comparison of the efficacy of 5% minoxidil, topical epinephrine, and placebo on the interval to chemotherapy-induced hair loss
Design
Participants will randomly be divided into three groups of 21 patients using a statistical software. All three groups will be matched for age, sex, and other demographic characteristics.This phase-3 study is a parallel group, double blind, randomized controlled trial.
Settings and conduct
Eligible patients will receive the drugs 1 hour before, during, and 1 month after chemotherapy. They will be examined every 2-3 weeks and trichoscopy will be performed using the FotoFinder at the beginning, the second or third time, the last time, and 1 month after chemotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with breast cancer referred to Shohadaye Tajrish Hospital for chemotherapy including adriamycin, cyclophosphamide, and taxol in 2020-2021, informed consent to participate in the study. Exclusion criteria: Presence of metastasis or inflammatory scalp disease, other causes of hair loss such as telogen effluvium, lichen planopilaris, discoid lupus erythematosus, and pregnant or lactating women
Intervention groups
Participants will randomly be divided into three groups of 21 patients using a statistical software. One group will receive 5% minoxidil, the second group will receive 5 micro gram topical epinephrine, and the third group will receive placebo (1 ml alcohol) twice a day.
Main outcome variables
age, gender, duration of chemotherapy, doses of drugs, efficacy of drugs, severity of drug complications, marital status, education, occupation, presence of metastasis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200205046380N1
Registration date: 2020-03-16, 1398/12/26
Registration timing: registered_while_recruiting

Last update: 2020-03-16, 1398/12/26
Update count: 0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
khatere zahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 5103
Email address
khaterezahedi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 5% minoxidil and topical epinephrine on the prevention of chemotherapy-induced hair loss in patients with breast cancer compared to the control group (placebo recipients)
Public title
Comparison of the effect of 5% minoxidil and topical epinephrine on the prevention of chemotherapy-induced hair loss in patients with breast cancer compared to the control group (placebo recipients) in 1398-1399
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast cancer referred to Shohadaye Tajrish Hospital for chemotherapy including adriamycin, cyclophosphamide, and taxol in 2020-2021 Informed consent to participate in the study
Exclusion criteria:
Presence of metastasis Presence of inflammatory scalp diseases Patients with other causes of hair loss including telogen effluvium, lichen planopilaris, and discoid lupus erythematosus Pregnant or lactating women
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 63
More than 1 sample in each individual
Number of samples in each individual: 21
63 patients will randomly be divided into 3 groups of 21 individuals eligible to enter the study
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into three blocks (A, B, and C) by block randmoization. Each block will contain 21 patients. A random allocation software will determine which patients go into which block. Then the three interventions including 5% minoxidil, topical epinephrine, and placebo will randomly be assigned to blocks A, B, or C.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the principle investigator, all the participants, and the data analyzer will be blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.SBMU.SRC.REC.1398023

Health conditions studied

1

Description of health condition studied
Chemotherapy-induced hair loss
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The evaluation of anagen hair count in trichoscopic findings of patients
Timepoint
The first time, the second or third time, the last time and one month after chemotherapy
Method of measurement
FotoFinder device

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group will receive 1 ml of 5% minoxidil prepared by Shahid Beheshti Pharmacology Group twice a day.
Category
Prevention

2

Description
The second intervention group will receive 1 ml of topical epinephrine solution prepared by Shahid Beheshti Pharmacology Group twice a day.
Category
Prevention

3

Description
The third intervention group will receive 1 ml of alcohol (placebo) prepared by Shahid Beheshti Pharmacology Group twice a day.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Dr. Mohammad Mehdi Forouzanfar
Street address
Shohadaye Tajrish Hospital, Tajrish Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
+98 21 2271 9014
Email
pr_shohada@sbmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Gholmali Tabarsa
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Fax
+98 21 2243 1919
Email
pr.office@mail.sbu.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
Khetere Zahedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 3, Sahand Tower, Vanak Park Complex, Alikhani Blvd., South Shiraz Ave., Kordestan St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1436943415
Phone
002188045103
Email
khaterezahedi4819@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khatere Zahedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 3, Sahand Tower, Vanak Park Complex, Alikhani Blvd., South Shiraz Ave., Kordestan St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14369-43415
Phone
+98 21 8804 5103
Email
khaterezahedi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khatere Zahedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 3, Sahand Tower, Vanak Park Complex, Alikhani Blvd., South Shiraz Ave., Kordestan St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14369-43415
Phone
+98 21 8804 5103
Email
khaterezahedi@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
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
Information about the timing of diagnosis of breast cancer, the stage of the disease, the time of first episode of chemotherapy, the intervals of chemotherapy, the type of medication used by the patient, the side effects of the drug, and the analysis of trichoscopic data (with FotoFinder device).
When the data will become available and for how long
The data can be accessed after the publication of the results
To whom data/document is available
People working in academic and scientific institutions
Under which criteria data/document could be used
Data can only be used to improve individuals' disease condition.
From where data/document is obtainable
Dr. Khatere Zahedi 00989132154819 khaterezahedi4819@gmail.com
What processes are involved for a request to access data/document
Request via email with complete identification data of the individual, the institution he/she works in, thorough explanation of the reason of the request. Data can be accessed after investigation of the responsible agent.
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