Spots Global Cancer Trial Database for Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Cisplatin Contained Chemotherapy in NSCLC Patients

Official Title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by First-line Chemotherapy Contained Cisplatin in Non-small Cell Lung Cancer Patients.

Study ID: NCT01882621

Conditions

Non-small Cell Lung Cancer

Interventions

Monosialoganglioside(GM1)

normal saline

Study Description

Brief Summary: Evaluate the efficacy and safety of Monosialoganglioside(GM1) to prevent the neurotoxicity induced by cisplatin

Detailed Description: NSCLC patients received a cisplatin-based doublet chemotherapy are included in this trial. Patients are randomly assigned into the experimental group and control group based on segmented block randomized method. After enrollment, patients should complete four or six chemotherapy and GM1/placebo injection. During the 3w per cycle chemotherapy, cisplatin injection is conducted in D1/D1-3, GM1/placebo (80mg+250ml N.S) is injected from D0 to D3. Neurotoxicity evaluation and quality of life (FACT-NTX and EROTC scale) assessment will be conducted every cycle and 3w/11w/19w after the chemotherapy.