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.
This study was randomly divided into two groups at a ratio of 1:1, with 176 subjects in each group. All patients received GM1/ placebo treatment + chemotherapy. The main purpose of this study is to evaluate the effectiveness of GM1 in preventing peripheral neuropathy caused by albumin-paclitaxel chemotherapy. The primary endpoint was the end of GM1 treatment in cycle 4 (C4D21), and the proportion of patients whose FACT/GOG-Ntx score changed by more than 12 points from baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
352
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 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.
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, China
RECRUITINGFACT/GOG-Ntx scores with a change of more than 12 points from the baseline
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
Time frame: At the end of Cycle 4 (21day/Cycle)
The incidence of grade ≥2 (CTCAE) CIPN
The incidence of grade ≥2 (CTCAE) CIPN
Time frame: At the end of Cycle 4 (21day/Cycle),At the end of Cycle 6 (21day/Cycle)
Assessment of functional impairment
Vibration sensitivity test and Grooved pegboard test
Time frame: At the end of Cycle 4 (21day/Cycle),At the end of Cycle 6 (21day/Cycle)
Assessment of Quality of Life
Assessment of Quality of Life(QLQ C30)
Time frame: At the end of Cycle 4 (21day/Cycle),At the end of Cycle 6 (21day/Cycle)
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the sixth cycle of treatment
Time frame: At the end of Cycle 6 (21day/Cycle)
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