Clinical trial · Interventional
Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer
The Effect of Monosialotetrahexosyl Ganglioside (GM1) in Prevention of Taxanes Induced Neurotoxicity in Breast Cancer Patients Who Received Taxanes-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Taxane plays a key role in the treatment of breast cancer and taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect leading to treatment discontinuation. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. However, the effects of GM1 on TIPN in breast cancer patients remains unknown. Purpose: This randomized phase III trial is designed to evaluate the potential effects of GM1 for preventing TIPN in breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ganglioside-monosialic acid | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ganglioside-monosialic acid arm
- description
- Patients will receive treatment of adjuvant chemotherapy. Ganglioside-monosialic acid(GM1, 80mg per day) will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2). Chemotherapy regimens: Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 \*4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 \*4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses. The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians.
- interventionNames
- Drug: Ganglioside-monosialic acid
- type
- PLACEBO_COMPARATOR
- label
- placebo arm
- description
- Patients will receive treatment of adjuvant chemotherapy. Placebo will be given at 1 day before the start of chemotherapy for three days (Day -1, 1 and 2). Chemotherapy regimens: Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by paclitaxel (175 mg/m2 \*4 cycles) after four courses of chemotherapy; Epirubicin (90 mg/m2) combined with cyclophosphamide (600 mg/m2) followed by docetaxel (75 mg/m2 \*4 cycles) after four course of chemotherapy; Docetaxel (75 mg/m2 q21d) combined with cyclophosphamide (600 mg/m2) for four courses. The first day (D1) of each cycle is treated with taxane-based chemotherapy. 14-21 days are usually as one cycle. The methods of pretreatment and hydration shall be decided by the physicians.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Enrollment Criteria: * Female patients with histologically confirmed early-stage breast cancer at the age of ≥18 and ≤75 , who have received radical surgical treatment of breast cancer (including modified radical mastectomy and breast-conserving surgery) while have not received neoadjuvant chemotherapy. EC\*4-T\*4 chemotherapy (T is paclitaxel or docetaxel) protocol is expected, and there is no herceptin indication or the patients are voluntarily not to be treated with herceptin. * Patients with KPS(Karnofsky Performance Status) scores ≥ 80; * Patients with ECOG score ≤ 1; * Expected survival ≥ 3 months; * The functional level of main organs must meet the following requirements (no blood transfusion, no leucocyte or platelet-ascending drugs used within 2 weeks before screening):1)Blood Routine: Neutrophil (ANC) ≥ 1.5 x 109/L;Platelets (PLT) ≥ 90 x 109/L; Hemoglobin (Hb) ≥ 90 g/L;2) Blood Biochemistry Total bilirubin (TBIL) ≤ 1.5 x ULN;L-Alanine (ALT) and aspartic transaminase (AST) ≤ 2 x ULN;Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 x ULN; * Cooperate to complete questionnaire accurately recording occurrence and severity of neurotoxicity * Sign the informed consent form. Exclusion Criteria: * There are any toxicity events of peripheral nervous system before enrollment, including: FACT-Ntx subscale score \< 44;≥ Grade 1 peripheral toxicity according to CTCAE Version 4.0 rating scale;≥ Grade 1 peripheral toxicity according to ENS rating scale;All other pathological symptoms or diseases might affect the evaluation of adverse neurotoxic effects * Patients having received other drug treatments might cause similar adverse neurotoxic effects within 4 weeks prior to the treatment of this protocol, or receive concurrent neurotoxic drugs. Including: Taxanes or analogues; Vinca alkaloids or analogues; Platinums or analogues; Cytarabine, thalidomide, bortezomib, or procarbazine; Other drugs or treatments might cause peripheral neurotoxicity * Patients in poor general conditions, with KPS (Karnofsky performance status) scores \< 80; * Pregnant or lactating women; * Patients (female) having the possibility of fertility but unwilling or not taking effective contraceptive measures * Patients also having other neurological abnormalities who cannot accurately record the occurrence and severity of neurotoxicity; * Patients known allergy to trial drugs or excipient compositions of these products; * Patients with inherited glucose and lipid metabolism abnormalities (gangliosidosis such as amaurotic family idiocy and retinopathy); * Patients not suitable for treatment of ganglioside; * Active infection (depending on the judgment of investigators); * Patients with serious concurrent diseases might harmful to safety and interfere the scheduled treatment or concomitant diseases might affect the completion of the study, depending on the judgment of investigators. * Patients with a history of definite neurological or dysphrenia, including epilepsy or dementia.
References
Publications (0)
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