Prospective Observational Investigation of Serum Interleukin-20 Level and Paclitaxel-Associated Neuropathy in Breast Cancer Patients Receiving Paclitaxel Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relationship with paclitaxel associated neuropathy and serum IL-20 level
研究概览
简要总结
This study aims to investigate the correlation between paclitaxel-induced neuropathy and the measurement values of serum IL-20 levels at baseline and during chemotherapy in patients who will receive neoadjuvant or adjuvant paclitaxel chemotherapy with the diagnosis of early-stage or locally advanced breast cancer
详细描述
- Patients with the diagnosis of breast cancer who will be started on adjuvant or neoadjuvant paclitaxel chemotherapy will be included in the study.
- Patients who will receive standard breast cancer treatment (4 cycles of cyclophosphamide 600mg/m2 every 21 days + epirubicin 90mg/m2 followed by weekly paclitaxel 80 mg/m2 x 12 sessions) will be included in the study.
- Age, gender, additional disease, diagnosis dates, previous diseases and breast cancer subtypes of the patients who signed the informed consent form will be obtained from the electronic information system or by asking face-to-face.
- Serum IL-20 level will be studied from blood tests taken for routine chemotherapy. no extra blood sample will be taken for the study
- Neuropathy assessment will be evaluated with Organisation for Research and Treatment of Cancer (EORTC) chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) Questionnaire, the sensitivity, and specificity of which have previously been demonstrated for chemotherapy-induced neuropathy. The Turkish validation questionnaire of the study, which was made before, will be conducted by the physician in charge before the paclitaxel chemotherapy and at the 1st and 12th weeks after the treatment, by asking the patient face to face.
- patients with diabetes mellitus and patients who had a history of peripheral neuropathy will be excluded from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •patients receiving paclitaxel chemotherapy for local advanced or early-stage breast cancer
- •>18 years
排除标准
- •advanced stage breast cancer
- •having before peripheral neuropathy
- •patients with diabetes mellitus
- •< 18 years
结局指标
主要结局
Relationship with paclitaxel associated neuropathy and serum IL-20 level
时间窗: December 31, 2022 is the deadline for patient inclusion
Neuropathy measurement will be made face-to-face by the attending physician with a European Organisation for Research and Treatment of Cancer (EORTC) Chemotherapy-induced peripheral neuropathy (CIPN) Questionnaire after the first week after paclitaxel chemotherapy and the last week of 12 cycles of treatment
次要结局
未报告次要终点
研究者
Asoc. Prof. Erdoğan Selçuk Şeber
Asoc Prof.
Namik Kemal University