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GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel

NCT04538833 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-11-23

No results posted yet for this study

Summary

Taxane-induced peripheral neuropathy (TIPN) caused by albumin-bound 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.

Conditions

  • Early Breast Cancer

Interventions

DRUG

monosialic gangliosides

The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin-bound paclitaxel(GM1 is a single infusion).

OTHER

Placebo

The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion)

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Zhenzhen Liu · Henan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2022-08-22
Completion
2022-08-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538833 on ClinicalTrials.gov