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

Neurotoxicity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02500810
• Other study ID #: GW-N-1501
• Status: Recruiting
• Phase: Phase 2
• First received: July 11, 2015
• Last updated: July 16, 2015
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: Jian Fang, MD
• Phone: 86-010-88196479
• Email: bcht2_mj[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurotoxicity
• Neurotoxicity Syndromes

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (9)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Beijing Shijitan Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University Third Hospital, Weifang People's Hospital, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time(days) of neurotoxicity adverse events alleviation		up to 180 days after the albumin-bound paclitaxel chemotherapy	No
Other	quality of life		up to 4 weeks after the albumin-bound paclitaxel chemotherapy	No
Other	side effects of monosialoganglioside		up to 4 weeks after the albumin-bound paclitaxel chemotherapy	Yes
Primary	incidence of neurotoxicity		up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy	No
Secondary	time(days)neurotoxicity arise		up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy	No
Secondary	Peripheral nerve conduction velocity		up to 4 weeks after the albumin-bound paclitaxel chemotherapy	No