GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

June 30, 2027

Conditions
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

Unknown

RECRUITING

The Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY