NCT02500810

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

July 11, 2015

Last Update Submit

July 16, 2015

Conditions

Neurotoxicity

Keywords

neurotoxicitychemotherapymonosialogangliosideprevention

Outcome Measures

Primary Outcomes (1)

  • incidence of neurotoxicity

    up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy

Secondary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

monosialoganglioside

EXPERIMENTAL

patients receive monosialoganglioside.

Drug: monosialoganglioside

control

NO INTERVENTION

blank control

Interventions

monosialogangliosideDRUG

40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.

Also known as: GM1, Monosialotetrahexosylganglioside Sodium Injection
monosialoganglioside

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System DiseasesPoisoningChemically-Induced Disorders

Study Officials

  • Jian Fang

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Fang, MD

CONTACT

86-010-88196479bcht2_mj@163.com

Xiangjuan Ma

CONTACT

86-010-88196459juliamarsh@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Thoracic Onconlogy Department

Study Record Dates

First Submitted

July 11, 2015

First Posted

July 17, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

CN(1)