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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2022
  • participants needed
    84
  • sponsor
    Henan Cancer Hospital
Updated on 28 January 2021

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.

Details
Condition Early Breast Cancer
Treatment Placebo, monosialic gangliosides
Clinical Study IdentifierNCT04538833
SponsorHenan Cancer Hospital
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients diagnosed with early breast cancer by histology
Age 18 years old and 75 years old
At least 1-2 cycles of standard chemotherapy regimens containing albumin-bound paclitaxel were used in adjuvant / neoadjuvant chemotherapy regimens, The FACT-Ntx score was 37, and the remaining chemotherapy cycles were at least 2 cycles. the standard regimen included: a, albumin paclitaxel one-week regimen; b, albumin paclitaxel 3-week regimen. Platinum and other types of neurotoxic drugs shall not be included in the regimen
ECOG score of the patient is 1
Expected survival time 3 months
The function level of main organs must meet the following requirements (no blood transfusion and no use of leukocyte or platelet rising drugs within 2 weeks before screening) Blood routine: neutrophil (ANC) 1.5x 10^9 / L; platelet (PLT) 90x10^9 / L; hemoglobin (Hb) 90g / L; Blood biochemical total bilirubin (TBIL) 1.5xULN; alanine aminotransferase (AST) and aspartate aminotransferase (AST) not exceeding 2ULN; blood urea nitrogen (BUN) and creatinine (CR) below 1.5 ULN
FACT-Ntx score is 44 points before the adjuvant / neoadjuvant chemotherapy was given
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Exclusion Criteria

Other pathological symptoms or diseases may affect the assessment of adverse neurotoxicity before enrollment
Patients receiving other medications may cause similar adverse neurotoxic effects within 4 weeks before treatment with this regimen, or they may also receive neurotoxic medications at the same time. Including paclitaxel or analogues; vinca alkaloids or analogues; platinums or analogues; cytarabine, thalidomide, bortezomib or cabazine; other drugs or treatments may cause peripheral neurotoxicity
Patients with poor overall condition and ECOG score> 1
pregnant or lactating women
Patients who also suffer from other neurological abnormalities cannot accurately record the occurrence and severity of neurotoxicity
The patient is known to be allergic to the test drug or excipient ingredients of these products
Patients with hereditary abnormalities of glucose and lipid metabolism (gangliopathies, such as idiopathic and retinopathy of triad families)
Patients not suitable for ganglioside treatment
Patients with severe concurrent diseases may endanger safety and interfere with scheduled treatment, or the combination of diseases may affect the completion of the study, depending on the judgment of the investigator
Patients with a clear history of neurological or mental disorders, including epilepsy or dementia
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