Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04222790
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2020-01-07
Brief Title:
A Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
A Multicenter Double-blind Randomized Controlled Phase II Clinical Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None