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GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer(Gypsophila )
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2025-08-01
Completion Date
2027-06
Last Updated
2025-08-06
Healthy Volunteers
No
Interventions
GM1
GM1 was administered intravenously one day before the administration of each cycle of chemotherapy. The experimental group was given 400 mg of GM1 injection. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.
Placebo
Placebo was administered intravenously one day before the administration of each cycle of chemotherapy. The control group was given placebo. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.
Locations (1)
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, China