RecruitingPhase 3NCT06994507

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

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 )


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

352 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called GM1 (a naturally occurring substance) can prevent nerve damage in the hands and feet — a painful side effect called peripheral neuropathy — in women with breast cancer who are receiving a type of chemotherapy called nab-paclitaxel (albumin-bound paclitaxel). **You may be eligible if...** - You are a woman aged 18 to 75 with a confirmed breast cancer diagnosis - You are planned to receive nab-paclitaxel as part of your chemotherapy treatment - Your blood sugar is well controlled (HbA1c under 7.0%) - Your organs (heart, liver, kidneys) are functioning adequately **You may NOT be eligible if...** - You already have any nerve damage or tingling in your hands/feet - You have other known risk factors for nerve damage unrelated to chemotherapy - You have a history of another cancer (other than breast) - You have HIV, active hepatitis B or C, syphilis, or hereditary fat metabolism disorders - You have uncontrolled heart or blood vessel disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGM1

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.

DRUGPlacebo

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

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NCT06994507


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