ABCB1 Single Nucleotide Polymorphism Genotypes as Predictors of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Grade 2 or higher peripheral neuropathy
研究概览
简要总结
The study aim is to determine the allele frequencies of 1236 G>A and 3435 G>A in ABCB1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in Egyptian patients. Additionally, the study aimed at fitting and validating logistic regression models with the aforementioned SNPs evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Egyptian females ≥18 years of age.
- •Histologically confirmed Breast Cancer.
- •Receiving conventional neoadjuvant or adjuvant weekly paclitaxel.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (UNL), total bilirubin ≤1.5x UNL, absolute neutrophil count ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, AST and ALT ≤3.0x UNL, and alkaline phosphatase ≤3.0x UNL).
- •No major neurological disease or symptoms prior to the start of paclitaxel therapy.
- •neither subjective nor objective evidence of metastatic disease.
排除标准
- •Patients with recurrent or metastatic (local or distant) breast cancer.
- •Neuropathic at the time of recruitment.
- •History of neuropathy prior to recruitment.
- •Previously exposed to taxanes or any other microtubule Inhibitors, or regimens including platinates.
- •Patients currently receiving dose-dense biweekly taxane-containing regimens.
结局指标
主要结局
Grade 2 or higher peripheral neuropathy
时间窗: 12 weeks
Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0)
次要结局
未报告次要终点
研究者
nabil mahmoud
Master's Student
Ain Shams University