A Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity
Condition: Early Breast Cancer
MeSH terms: Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Taxane-induced peripheral neuropathy (TIPN) caused by paclitaxel is a dose-limiting toxicity.
      The main symptoms of discomfort are numbness, tingling, and burning sensations in the
      glove-sock-like distribution of the limbs. At present, there are few effective methods for
      clinical treatment of TIPN, and there is no widely agreed consensus on effective treatment in
      the world. Therefore, it is of great clinical significance and practical value to carry out
      clinical research to explore drugs to relieve TIPN.
    

Detailed description: 
      Taxane induced peripheral neuropathy (TIPN) caused by taxol is a dose limiting toxicity. The
      discomfort symptoms mainly include numbness, tingling and burning sensation in the glove sock
      like distribution of the extremities. This symptom can lead to limited activity, damage the
      self-care ability and social function of patients, and significantly reduce the quality of
      life of patients, At the same time, it may lead to early termination of chemotherapy and
      affect tumor treatment. The overall incidence of TIPN is very high. Many studies show that
      the incidence of TIPN is as high as 80%. CTCAE classifies it into 5 grades, and 25% - 30% of
      patients can have serious neurotoxicity. However, there are few effective methods for
      clinical treatment of TIPN, and there is no international consensus on effective treatment.
      Therefore, it is of great clinical significance and practical value to carry out clinical
      research on drugs to alleviate TIPN.

      Monosialoganglioside (GM1), a member of the ganglioside family, is a kind of
      glycosylsphingolipid containing sialic acid on the cell membrane of mammalian animals. It is
      an endogenous substance. Gangliosides are mainly distributed in the outer layer of the cell
      membrane, especially on nerve endings and dendrites. It is most abundant and mainly expressed
      in the cell membrane of neurons. It participates in a variety of neurobiological activities,
      including neuronal differentiation Plasticity and cell survival. There is evidence that the
      application of GM1 can protect nerve cells, promote the recovery of neural function, and
      reduce the time of disability. Recent clinical studies on gangliosides have also shown
      promising results. GM1 effectively alleviates the neurotoxicity caused by docetaxel.

      Although there have been previous studies on the effect of gangliosides on relieving the
      neurotoxicity of docetaxel, studies on the effect of gangliosides on relieving albumin bound
      paclitaxel have not been seen, and prospective clinical research data of large samples are
      lacking. In conclusion, the researchers hope to explore effective and reliable drugs to
      alleviate the peripheral neurotoxicity of albumin bound paclitaxel.
    

Intervention name(s): monosialic gangliosides; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin paclitaxel (GM1 is a single infusion).; The control group received placebo on days -1, 1, and 2 of albumin paclitaxel (placebo as a single infusion)
Other intervention name(s): experience group; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment