NCT04222790

A Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity

A Multicenter, Double-blind, Randomized Controlled Phase II Clinical Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Breast Cancer

Interventions

Type	Name	Description
DRUG	monosialic gangliosides	The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin paclitaxel (GM1 is a single infusion).
OTHER	Placebo	The control group received placebo on days -1, 1, and 2 of albumin paclitaxel (placebo as a single infusion)

Timeline

• Start date: 2020-08-28
• Primary completion: 2022-04-21
• Completion: 2022-04-21
• First posted: 2020-01-10
• Last updated: 2023-12-04

Locations

1 site across 1 country: China