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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
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.
Details
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 206 |
| Start date | 2015-05 |
| Completion | 2016-12 |
Conditions
- Breast Cancer
Interventions
- Ganglioside-monosialic acid
- placebo
Primary outcomes
- the Functional Assessment of Cancer Treatment Neurotoxicity (FACT-Ntx) subscale between groups at 2 weeks after the 4-cycle chemotherapy — Day 1 of Week 1 to 1 year after the last course of chemotherapy
The primary endpoint was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT -Ntx) subscale at 2 weeks after completion of 4-cycles of taxane-based chemotherapy. FACT-Ntx subscales contains 11 items including numbness, tingling, and discomfort in the hands or feet; difficulty hearing or tinnitus; joint pain or muscle cramps; weakness or fatigue; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand; feeling pain or hard to breath when exposed to low temperature. Each Items is scored from 0 to 4 with a total score of 44; higher scores indicate better performance. A 5-point difference in the FACT-Ntx subscale scores between groups is considered clinically meaningful. The FACT-Ntx subscales assessments were performed at 2 weeks after each course of chemotherapy. Additional long-term assessments were performed at 3 months, 6 months and 1 year after the end of chemotherapy.
Countries
China