GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- FACT/GOG-Ntx scores with a change of more than 12 points from the baseline — At the end of Cycle 4 (21day/Cycle)
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the fourth cycle of treatment
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Fifth Medical Center of the Chinese People's Liberation Army General Hospital | Beijing | China | Recruiting |
More Qilu Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06994507 on ClinicalTrials.gov ↗ ← All trials in China