Trials / Withdrawn
WithdrawnNCT04538833
GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel
Monosialoganglioside in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel : a Multicenter, Double-blind, Randomized Controlled Phase II Clinical Trial
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (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 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
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-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) |
Timeline
- Start date
- 2020-09-09
- Primary completion
- 2022-08-22
- Completion
- 2022-08-22
- First posted
- 2020-09-04
- Last updated
- 2022-11-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04538833. Inclusion in this directory is not an endorsement.