Not provided
Not provided
Not provided
Not provided
Not provided
In the clinical treatment, no patient with a score of less than 38(FACT Ntx Score) points after 1-2 weeks of application of albumin bound paclitaxel in this project, therefore, there is no suitable subject after screening
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monosialic ganglioside | Experimental | On the days -1, 1, and 2 of albumin-bound paclitaxel application, 80 mg of monosialic ganglioside were applied (monosialic ganglioside was a single infusion) |
|
| Placebo | Placebo Comparator | The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel application, (placebo as a single infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monosialic gangliosides | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| FACT-Ntx score | The FACT-Ntx subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. Higher scores indicate lower side effects | 2 weeks after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| CTCAE Version 4.0 score | Peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, myalgia, arthralgia, and neuralgia were evaluated by the CTCAE 4.0 rating scale. Each item was divided into 5 levels: 1, 2, 3, 4, 5, Higher indicates higher neurotoxicity | During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhenzhen Liu | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion) |
|
| FACT-Taxane score | The FACT-Taxane scale contains 16 items, each item is divided into 5 grades: 0, 1, 2, 3, 4, with a total score of 64. The higher the score, the lower the side effects. | During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy |
| FACT-G score | The FACT-G Scale contains 27 items, each item is divided into 5 grades: 0, 1, 2, 3, 4, with a total score of 108 | During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy |
| FACT-Ntx score | The FACT-Ntx subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. Higher scores indicate lower side effects | 3 months, 6 months, and 12 months after chemotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |