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

Primary Purpose

Neurotoxicity

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
monosialoganglioside
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurotoxicity focused on measuring neurotoxicity, chemotherapy, monosialoganglioside, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

monosialoganglioside

control

Arm Description

patients receive monosialoganglioside.

blank control

Outcomes

Primary Outcome Measures

incidence of neurotoxicity

Secondary Outcome Measures

time(days）neurotoxicity arise
Peripheral nerve conduction velocity

Full Information

First Posted
July 11, 2015
Last Updated
July 16, 2015
Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Peking University First Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Shijitan Hospital, Capital Medical University, Yantai Yuhuangding Hospital, Weifang People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02500810
Brief Title
Monosialoganglioside Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
Official Title
A Randomized, Controlled, Multicenter Phase II Clinical Trial of Monosialoganglioside(GM1) Preventing Neurotoxicity Induced by Albumin-bound Paclitaxel Chemotherapy in Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Peking University First Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Shijitan Hospital, Capital Medical University, Yantai Yuhuangding Hospital, Weifang People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotoxicity
Keywords
neurotoxicity, chemotherapy, monosialoganglioside, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
monosialoganglioside
Arm Type
Experimental
Arm Description
patients receive monosialoganglioside.
Arm Title
control
Arm Type
No Intervention
Arm Description
blank control
Intervention Type
Drug
Intervention Name(s)
monosialoganglioside
Other Intervention Name(s)
GM1, Monosialotetrahexosylganglioside Sodium Injection
Intervention Description
40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.
Primary Outcome Measure Information:
Title
incidence of neurotoxicity
Time Frame
up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy
Secondary Outcome Measure Information:
Title
time(days）neurotoxicity arise
Time Frame
up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy
Title
Peripheral nerve conduction velocity
Time Frame
up to 4 weeks after the albumin-bound paclitaxel chemotherapy
Other Pre-specified Outcome Measures:
Title
time(days) of neurotoxicity adverse events alleviation
Time Frame
up to 180 days after the albumin-bound paclitaxel chemotherapy
Title
quality of life
Time Frame
up to 4 weeks after the albumin-bound paclitaxel chemotherapy
Title
side effects of monosialoganglioside
Time Frame
up to 4 weeks after the albumin-bound paclitaxel chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Fang, MD
Phone
86-010-88196479
Email
bcht2_mj@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangjuan Ma
Phone
86-010-88196459
Email
juliamarsh@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Fang
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangjuan Ma
Phone
86-010-88196458
Email
juliamarsh@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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