Clinical Trial: Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lun
Brief Summary: The purpose of this study is to determine whether monosialoganglioside are effective in the prevention of neurotoxicity induced by albumin-bound paclitaxel chemotherapy in lung cancer patients, and improve the quality of life of patients.
Detailed Summary: Lung cancer patients received a single-agent albumin-bound paclitaxel chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and blank control group based on segmented block randomized method. After enrollment, patients will complete at least chemotherapy and GM1 injection/blank control. During the 3w per cycle chemotherapy, albumin-bound paclitaxel is conducted in D1 and D8, GM1(40mg+250ml N.S) is injected from D1 to D8. Neurotoxicity evaluation and quality of life assessment will be conducted every cycle and 3m/6m after the chemotherapy.
Sponsor: Beijing Cancer Hospital
Current Primary Outcome: incidence of neurotoxicity [ Time Frame: up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- time(days）neurotoxicity arise [ Time Frame: up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy ]
- Peripheral nerve conduction velocity [ Time Frame: up to 4 weeks after the albumin-bound paclitaxel chemotherapy ]
Original Secondary Outcome: Same as current
Information By: Beijing Cancer Hospital
Dates:
Date Received: July 11, 2015
Date Started: July 2015
Date Completion: December 2018
Last Updated: July 16, 2015
Last Verified: July 2015
