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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Collaborators: Beijing Shijitan Hospital; Beijing Shijitan Hospital, Capital Medical University; 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
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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