The effect of adding Desloratadine to neoadjuvant chemotherapy in patients with breast cancer

Phase 2

Recruiting

• Conditions: Breast cancer.; Malignant neoplasm of breast

• Registration Number: IRCT20230221057485N1
• Lead Sponsor: Gorgan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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 Outcome Measures

Name	Time	Method
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.;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.;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.;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).