Effects of Pharmacogenetics on Pharmacokinetics and Toxicity of Doxorubicin in Egyptian Breast Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Menoufia University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Doxorubicin plasma concentrations
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study aims to investigate the effect of single nucleotide polymorphisms (SNPs) of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients.
It also aims to explore the association of pretreatment neutrophil to lymphocyte ratio (NLR) with pathological complete response (pCR).
Detailed Description
Plasma concentrations of doxorubicin will be determined and venous blood samples will be obtained from each patient for SNP genotyping of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients \[prospective study\]. A complete blood count was carried out at baseline for patients receiving neoadjuvant chemotherapy. The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes \[ retrospective study\].
Investigators
Naglaa Fathy Mohamed Ebaid
Assistant Lecturer of clinical pharmacy
Menoufia University
Eligibility Criteria
Inclusion Criteria
- •Females aged ≥ 18 years
- •Performance status 0 or 1
- •No contraindication to chemotherapy
- •Adequate bone marrow
- •Adequate hepatic function
- •Adequate renal function
Exclusion Criteria
- •Poorly controlled diabetes mellitus
- •Ischemic heart disease
- •Uncontrolled hypertension
- •Active infections
- •Baseline ejection fraction \< 50%
- •Performance status ≥ 2
- •Pregnancy Lactation, bilateral breast cancer, male patients, primary surgery, distant metastases, other malignancies, inflammations, hematological disorders, autoimmune diseases, and patients taking non-steroidal anti-inflammatory drugs (NSAIDs), steroidal and antibiotic therapy.
Outcomes
Primary Outcomes
Doxorubicin plasma concentrations
Time Frame: baseline
Plasma concentrations of doxorubicin will be determined using a suitable analytical method.
neutrophil to lymphocyte ratio
Time Frame: baseline
The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes.