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Investigation of the effect of adding Desloratadine to neoadjuvant chemotherapy on the response to treatment and some of inflammatory factors in breast cancer patients

Protocol summary

Study aim
Investigating the effect of adding Desloratadine to neoadjuvant chemotherapy in breast cancer patients
Design
The clinical trial has a control group, with parallel groups, single-blind, phase 3 of 104 patients with breast cancer, randomization will be done by stratified method and by simple random method.
Settings and conduct
This study is conducted in 5 Azar Hospital, Gorgan, in a single-blind way (patients do not know the type of their group), the control group is treated with neoadjuvant chemotherapy, and the intervention group is treated with neoadjuvant chemotherapy and Desloratadine 5mg, then at the end of 4 chemotherapy courses to evaluate the therapeutic response of the results with measurements RECIST standard and the level of serological tumor markers (CEA, CA15-3) are interpreted, blood samples of patients are measured to evaluate the serum level of cytokines, and gene expression changes in PBMC cells.
Participants/Inclusion and exclusion criteria
Inclusion criteria include having newly diagnosed breast cancer and being candidates for neoadjuvant chemotherapy, no use of antihistamines, no asthma, and not having other cancers at the same time as breast cancer. Exclusion criteria include patients with immune disorders Patients who are not eligible for chemotherapy for any reason. Patients who have undergone breast surgery
Intervention groups
The intervention group includes 52 breast cancer patients treated with neoadjuvant chemotherapy along with Desloratadine drug and the control group includes 52 breast cancer patients treated with neoadjuvant chemotherapy.
Main outcome variables
Determining response to treatment based on changes in tumor size and lymph node involvement based on standard RECIST criteria.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230221057485N1
Registration date: 2023-07-30, 1402/05/08
Registration timing: prospective

Last update: 2023-07-30, 1402/05/08
Update count: 0
Registration date
2023-07-30, 1402/05/08
Registrant information
Name
Hossein Azimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3336 8547
Email address
azimi.h@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-05-30, 1403/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of adding Desloratadine to neoadjuvant chemotherapy on the response to treatment and some of inflammatory factors in breast cancer patients
Public title
The effect of adding Desloratadine to neoadjuvant chemotherapy in patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed breast cancer who are candidates for neoadjuvant chemotherapy (including patients with axillary lymphadenopathy, infraclavicular and supraclavicular lymphadenopathy/tumor size greater than 2 cm in triple-negative and Her2-enriched patients/skin involvement/inflammatory breast cancer and a large ratio of tumor to total breast). Not using antihistamines (anti-H1R and H2R receptors) No asthma Not having other cancers at the same time as breast cancer
Exclusion criteria:
Patients with immunological disorders Patients who are not eligible for chemotherapy Patients who have undergone breast surgery
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a stratified manner. In this way, 34 people will be selected from among the qualified people in each of the classes. Then, by a simple random method (34 similar cards are prepared and the letter A is written on 17 cards and the letter B is written on the other 17 cards, and then the patients will be randomly assigned to groups.)
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (patients) who do not know their group type, control or intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Shasat Kala road, Hirkan Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2023-07-24, 1402/05/02
Ethics committee reference number
IR.GOUMS.REC.1402.121

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
Response rate to treatment based on changes in tumor size and lymph node involvement
Timepoint
At the beginning of the study and 2 months after the start of the first course of chemotherapy
Method of measurement
RECIST criteria

2

Description
The serum level of tumor serological markers (CEA, CA15-3)
Timepoint
At the beginning of the study and 2 months after the start of the first course of chemotherapy
Method of measurement
ELISA method

Secondary outcomes

1

Description
Serum level of Interleukin-6
Timepoint
At the beginning of the study and 2 months after the start of the first course of chemotherapy
Method of measurement
ELISA method

2

Description
Serum level of Tumor necrosis factor alpha
Timepoint
At the beginning of the study and 2 months after the start of the first course of chemotherapy
Method of measurement
ELISA method

3

Description
Serum level of Histamine
Timepoint
At the beginning of the study and 2 months after the start of the first course of chemotherapy
Method of measurement
ELISA method

4

Description
Expression level of Histamine receptor 1 (H1R), Toll-like receptor 4 (TLR4), and Nuclear factor kappa B (NF-kB)
Timepoint
At the beginning of the study and 2 months after the start of the first course of chemotherapy
Method of measurement
Real-time polymerase chain reaction (real-time PCR)

Intervention groups

1

Description
Intervention group: 52 patients with breast cancer are randomly included in the intervention group. In addition to the neoadjuvant chemotherapy process, desloratadine 5mg (Neotadine® tablets manufactured by Abidi Company, Iran) is prescribed daily (oral) until the patient is re-examined (about 2 months). At the end of 4 chemotherapy courses (every two weeks), breast ultrasound is performed again to evaluate the treatment response. then blood samples (7-10 cc) are taken and the amount of cytokines and gene expression changes in peripheral blood mononuclear cells are measured.
Category
Treatment - Drugs

2

Description
Control group: Control group: 52 patients with breast cancer are randomly included in the control group, this group is subjected to neoadjuvant chemotherapy (anthracyline base drugs) and prescribed until the patient's re-examination (about 2 months). At the end of 4 courses of chemotherapy (every two weeks), breast ultrasound is performed again to evaluate the treatment response, blood samples of the patients at the beginning and at the end of the study (2 months after the start of the treatment course) were taken in the amount of 7-10 cc and the amount cytokines and gene expression changes are measured in peripheral blood mononuclear cells.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
5 Azar Hospital, Gorgan
Full name of responsible person
Reza khandozi
Street address
Azar 6th, 5 Azar St., Gorgan
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3222 0561
Email
pr-5azar@goums.ac.ir

2

Recruitment center
Name of recruitment center
Dr. Reza Khandozi's office
Full name of responsible person
Reza khandozi
Street address
Unit 44, 4th Floor, Villa Building, 21 Adalat St., Valiasr Street.
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 911 175 2168
Email
drkhandoozi۹۲۰۰۲@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr.Narges beigom Mirbehbahani
Street address
Golestan University of Medical Sciences, Shasat Kala road, Hirkan Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
Info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Homa davoodi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Mina Gol Complex, 97 Edalat, Valiasr St.
City
Gorgan
Province
Golestan
Postal code
4917943760
Phone
+98 17 3255 7487
Email
drdavoodi@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Reza Khandozi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Unit 44, 4th Floor, Villa Building, 21 Adalat St., Valiasr Street.
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3255 7487
Email
drkhandoozi۹۲۰۰۲@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hossein azimi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Immunology
Street address
No.1, 1st Floor, Palladium 3 Complex, 2nd Alley, Sepahbod Qarani St., 17 Shahrivar East Blvd.
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971856777
Phone
+98 17 3336 8547
Email
Azimi.h@goums.ac.ir

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
No - There is not 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
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