JPRN-jRCT2032210115招募中未知
A double-blind randomized Control trial to Evaluate mitigation of CIpn by LImb-cooling Apparatus in breast cancer patients who undergo weekly paclitaxel - CECILIA
Mukohara Toru0 个研究点目标入组 150 人开始时间: 2021年5月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. 12 weekly doses of paclitaxel (80 mg/m2, 60-minute intravenous infusion) will be administered as perioperative treatment for clinical stage I-III breast cancer (concomitant use of trastuzumab and pertuzumab is allowed).
- •2. age 20 years or older on the date of enrollment.
- •3. ECOG Performance Status is 0 or 1.
- •4. freely and voluntarily give written consent to participate in the study.
- •Patients must have the following organ functions according to the results of clinical laboratory tests up to 14 days before the first dose of paclitaxel (tests on the same day of the week 14 days before the day of administration are acceptable). However, measurements within 7 days of blood transfusion or granulocyte colony stimulating factor (G-CSF) administration are excluded.
- •- Neutrophil count >= 1,000/mm3
- •- Platelet count >= 75,000/mm3
- •- Hemoglobin >= 8.0 g/dL
- •- Serum creatinine >= 2.0 mg/dL or calculated creatinine clearance (Cockcroft-Gault formula*) or measured creatinine clearance >= 50 mL/min
- •- T-Bil =< 1.5 mg/dL
- •- ALT and AST =< 100 U/L
- •Creatinine clearance = (140 - age) x body weight (kg) / (72 x serum creatinine level) (*For female patients, the obtained value should be further multiplied by 0.85)
- •6. after the first dose of paclitaxel, the investigator or sub-investigator has diagnosed that the second and subsequent doses of paclitaxel can be administered in 60 minutes.
排除标准
- •1. either CTCAE v5.0 grade 2 or higher peripheral sensory neuropathy or grade 1 or higher limb edema in any of the extremities as assessed at the time of enrollment.
- •2. loss of fingers or toes.
- •3. cooling is inappropriate due to complications such as cold coagulopathy, cold urticaria, Raynaud's symptom, peripheral arterial ischemia, hand-foot syndrome, etc.
- •4. A history of varicose veins or venous thrombosis of the lower extremities.
- •5. A history of diseases predisposing to coagulation, such as antiphospholipid antibody syndrome, protein C deficiency, protein S deficiency, or antithrombin deficiency.
- •6. Patients are scheduled to receive duloxetine or other neuropathy medications during the study period.
- •7. Severe alcohol sensitivity.
- •8. received any prior therapy (chemotherapy, molecular targeted therapy, antibody therapy, hormonal therapy, immunotherapy, radiation therapy) except trastuzumab and pertuzumab within 7 days prior to the first dose of paclitaxel.
- •9. not recovered (Grade 1 or lower or to baseline) from toxicity due to prior therapy. However, events with stable symptoms such as abnormal blood test results meeting selection criteria 5, Grade 2 alopecia, and Grade 2 hyperpigmentation of the skin are excluded.
- •10. history of hand or toe trauma or surgery within one month prior to enrollment.
- •11. poorly controlled diabetes mellitus, autoimmune neuropathy (Guillain-Barre syndrome, Fisher's syndrome, chronic inflammatory demyelinating polyneuropathy, etc.), and comorbid conditions that cause peripheral neuropathy such as cerebrovascular disease with incomplete or complete paralysis.
- •12. have undergone major surgery within 4 weeks prior to enrollment. However, breast cancer surgeries (total mastectomy, partial mastectomy, axillary lymph node dissection) and CV port construction will not be excluded if they were not performed within 2 weeks prior to enrollment.
- •13. The principal investigator or sub-investigator judges that the subject is unsuitable for enrollment in this clinical trial.
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