Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients

A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients

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.

Study Overview

• Status: Unknown
• Conditions: Neurotoxicity
• Intervention / Treatment: Drug: monosialoganglioside

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jian Fang, MD; Phone Number: 86-010-88196479; Email: bcht2_mj@163.com
• Study Contact Backup: Name: Xiangjuan Ma; Phone Number: 86-010-88196459; Email: juliamarsh@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Xiangjuan Ma; Phone Number: 86-010-88196458; Email: juliamarsh@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cytological and histological confirmation of unresectable locally advanced or metastatic lung cancer diagnosis
• No peripheral nervous system diseases exists before
• Within 4 weeks before treatment, did not receive other adverse reaction of drugs may cause similar neurotoxicity
• Enough organ functions reservation and appropriate performance status for chemotherapy
• Expected survival period is more than 3 months

Exclusion Criteria:

• Known or assignment of any of these products to test drugs allergic agent composition
• With peripheral neuropathy by any cause before treatment
• With other neurological dysfunction which can cause inaccurate record of the occurrence of neurotoxicity and severity
• Patients with poor general condition to receive chemotherapy
• Genetic glucolipid metabolic abnormalities
• Patients (male or female) have fertility possibility but not willing to or not to adopt effective contraception
• Patients cann't avoid neurotrophic drugs
• According to the researcher's judgment, the situations inappropriate for patients with ganglioside medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: monosialoganglioside; patients receive monosialoganglioside.	Drug: monosialoganglioside; 40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.; Other Names: GM1; Monosialotetrahexosylganglioside Sodium Injection
NO_INTERVENTION: control; blank control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of neurotoxicity	up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
time(days）neurotoxicity arise	up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy
Peripheral nerve conduction velocity	up to 4 weeks after the albumin-bound paclitaxel chemotherapy

Other Outcome Measures

Outcome Measure	Time Frame
time(days) of neurotoxicity adverse events alleviation	up to 180 days after the albumin-bound paclitaxel chemotherapy
quality of life	up to 4 weeks after the albumin-bound paclitaxel chemotherapy
side effects of monosialoganglioside	up to 4 weeks after the albumin-bound paclitaxel chemotherapy

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Peking University First Hospital; Peking Union Medical College Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese PLA General Hospital; Peking University Third Hospital; Beijing Shijitan Hospital, Capital Medical University; Yantai Yuhuangding Hospital; Weifang People's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: July 11, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (ESTIMATE): July 17, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: chemotherapy; prevention; neurotoxicity; monosialoganglioside
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Poisoning; Neurotoxicity Syndromes
• Other Study ID Numbers: GW-N-1501