GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GM1, Placebo.
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN). Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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 )
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- FACT/GOG-Ntx scores with a change of more than 12 points from the baseline [Time frame: At the end of Cycle 4 (21day/Cycle）]
Secondary outcome measures (4)
- 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 [Time frame: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）]
- Assessment of Quality of Life [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 [Time frame: At the end of Cycle 6 (21day/Cycle）]
Eligibility criteria
Inclusion criteria
- Voluntarily sign the informed consent form;
- Age: 18 to 75 years old;
- Female patients with breast cancer confirmed byhistological and/or cytological diagnostic basis for breast cancer and are intended to receive adjuvant/neoadjuvant therapy with Albumin paclitaxel regimens;
- ECOG: 0-1
- Adequate organ function level
- Glycated hemoglobin (HbA1c) < 7.0%;
- For women of childbearing potential: use effective contraceptive measures for contraception from the date of signing the informed consent form until 30 days after the last use of the investigatory drug.
- Patients can accurately record or express the occurrence and severity of peripheral neuropathy through questionnaires.
Exclusion criteria
- Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT/GOG-Ntx ≥1;
- There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).
- History of another malignant tumors (except breast cancer)
- Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;
- Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension
- Active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; Or infectious diarrhea occurred within 4 weeks before the first study drug use;
- Hereditary abnormal glycolipid metabolism, HIV infection or known Acquired Immune Deficiency Syndrome (AIDS); Positive syphilis antibody, active hepatitis B, active hepatitis C
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- The Fifth Medical Center of the Chinese People's Liberation Army General Hospital — Beijing
Identifiers
NCT: NCT06994507 · QLGM1-CIPN-301