NCT04446819Unknown不适用
A Multicenter Prospective Phase III Clinical Study of Reducing Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity of Upper Extremities With Compression Gloves (REMAINING)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Differences in severe peripheral sensory neurotoxicity rates
研究概览
简要总结
Nanoparticle albumin-bound paclitaxel has greater efficacy and favorable safety profile than standard paclitaxel. However, rate of neuropathy caused by nanoparticle albumin-bound paclitaxel is higher than standard paclitaxel, and is one of its dose-limited toxicities. Previously, compression therapy by surgical gloves has shown effectiveness in preventing chemotherapy-induced neuropathy. We designed this multi-center prospective self-control phase III study to investigate the efficacy of compression gloves to reduce albumin-binding paclitaxel induced sensory and motor neurotoxicity of upper extremities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are diagnosed with pathologically confirmed solid tumors.
- •Patients are about to receive albumin-binding paclitaxel monotherapy (at least 4 cycles anticipated) by physicians' choice.
- •Patients should have baseline Grade 0 peripheral sensory and motor neurotoxicity (NCI-CTCAE 5.0).
- •Eastern Cooperative Oncology Group performance status ≤
- •Biochemical tests within 7 days before inclusion should meet the following criteria:
- •Hemoglobin ≥ 90g/L, white blood cell count ≥ 3500/mm^3, neutrophil ≥ 1500/mm^3 and platelet ≥ 75000/mm^3 with no blood transfusion or hematopoietic colony-stimulating factors in the past 14 days.
- •Creatinine ≤ 1.5 times upper limit of normal (ULN).
- •Liver function: For patients without liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 1.5 times ULN, and total bilirubin ≤ 1.25 times ULN. For patients with liver metastasis, ALT, AST and ALP ≤ 5 times ULN and total bilirubin ≤ 1.5 times ULN.
- •Life expectancy ≥ 12 weeks.
- •No history of severe diseases in important organs including heart, lung, liver, and kidney.
- •Willingness to sign a written informed consent.
- •Willingness to adhere to dose and visit schedules.
- •Women of child-bearing ages should be willing to take birth control methods during treatment and within 8 weeks after trial, and pregnancy test (blood or urine) within 14 days before inclusion should be negative (if positive, ultrasound should be performed to rule out pregnancy). Male patients should be willing to take birth control methods during treatment and within 8 weeks after trial or be sterilized by surgery .
排除标准
- •Patients with uncontrolled and severe infection.
- •Patients with meningeal metastasis, symptomatic brain metastasis, spinal cord compression, or new discovery of brain or pia mater diseases during screening. Patients who finish brain local control treatment, manifest stable symptoms and without brain hemorrhage in radiological screening can be included in the trial.
- •Investigators decide the patient unsuitable for the trial.
- •Elimination Criteria:
- •Patients have allergy to albumin-binding paclitaxel and are unable to finish 4 cycles of treatment.
- •Patients are unable to finish 4 cycles of albumin-binding paclitaxel monotherapy due to intolerable toxicities even after twice dose reduction. If due to toxicity of peripheral neurotoxicity, evaluations should be performed and recorded for further case study.
- •Patients are unable to finish 4 cycles of albumin-binding paclitaxel monotherapy because of change of regimen due to progression or death.
- •Patients require to quit.
- •Patients are found to have situations that are not suitable for the trial after inclusion.
- •Patients' hands are unfit for the compression gloves used in the trial (too big or too small).
- •Any situations that investigators believe necessary for patients to quit the trial.
结局指标
主要结局
Differences in severe peripheral sensory neurotoxicity rates
时间窗: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in peripheral sensory neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
次要结局
- Differences in severe peripheral motor neurotoxicity rates(3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).)
- Differences in total peripheral motor neurotoxicity rates(3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).)
- Differences in total peripheral sensory neurotoxicity rates(3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).)
- Differences in peripheral neurotoxicity questionaire scores(3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).)
- Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.(From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).)
研究者
Jian Zhang,MD
Associate Professor
Fudan University
研究点 (1)
Loading locations...
相似试验
终止
2 期
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple MyelomaRefractory Plasma Cell MyelomaNCT01646762Mayo Clinic13
Unknown
2 期
Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic CancerAdvanced Pancreatic CancerNCT02124317Chinese PLA General Hospital60
Unknown
2 期
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic CancerAdvanced Pancreatic CancerNCT02135822Chinese PLA General Hospital30
终止
2 期
Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial CarcinomaUrothelial CarcinomaTransitional Cell CarcinomaBladder CancerNCT02887248SCRI Development Innovations, LLC3
已完成
3 期
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)Non-small Cell Lung CancerNCT02775435Merck Sharp & Dohme LLC559