Clinical trial NCT02500810: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neurotoxicity
Keywords: neurotoxicity
chemotherapy
monosialoganglioside
prevention
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University Third Hospital
name: Chinese PLA General Hospital
name: Peking Union Medical College Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Beijing Shijitan Hospital, Capital Medical University
name: Yantai Yuhuangding Hospital
name: Weifang People's Hospital
First posted: 2015-07-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: incidence of neurotoxicity
timeFrame: up to 4 weeks after the 2nd cycle albumin-bound paclitaxel chemotherapy
Secondary outcomes:
measure: time(days）neurotoxicity arise
timeFrame: up to 6 months neurotoxicity after the first use of albumin-bound paclitaxel chemotherapy
measure: Peripheral nerve conduction velocity
timeFrame: up to 4 weeks after the albumin-bound paclitaxel chemotherapy
Other outcomes:
measure: time(days) of neurotoxicity adverse events alleviation
timeFrame: up to 180 days after the albumin-bound paclitaxel chemotherapy
measure: quality of life
timeFrame: up to 4 weeks after the albumin-bound paclitaxel chemotherapy
measure: side effects of monosialoganglioside
timeFrame: up to 4 weeks after the albumin-bound paclitaxel chemotherapy
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jian Fang
role: PRINCIPAL_INVESTIGATOR
References: