Clinical trial NCT04538833: GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel
Official title: Monosialoganglioside in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel : a Multicenter, Double-blind, Randomized Controlled Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Early Breast Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Female patients diagnosed with early breast cancer by histology;
2. Age ≥18 years old and ≤75 years old
3. 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.
4. ECOG score of the patient is ≤1;
5. Expected survival time ≥ 3 months;
6. 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 2×ULN; blood urea nitrogen (BUN) and creatinine (CR) below 1.5 × ULN;
7. FACT-Ntx score is 44 points before the adjuvant / neoadjuvant chemotherapy was given;
8. Sign the informed consent.

Exclusion Criteria:

1. Other pathological symptoms or diseases may affect the assessment of adverse neurotoxicity before enrollment
2. 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;
3. Patients with poor overall condition and ECOG score\> 1;
4. pregnant or lactating women;
5. Patients who also suffer from other neurological abnormalities cannot accurately record the occurrence and severity of neurotoxicity;
6. The patient is known to be allergic to the test drug or excipient ingredients of these products;
7. Patients with hereditary abnormalities of glucose and lipid metabolism (gangliopathies, such as idiopathic and retinopathy of triad families);
8. Patients not suitable for ganglioside treatment;
9. 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.
10. Patients with a clear history of neurological or mental disorders, including epilepsy or dementia.

Primary outcomes:
measure: FACT-Ntx score
timeFrame: 2 weeks after chemotherapy
Secondary outcomes:
measure: CTCAE Version 4.0 score
timeFrame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
measure: FACT-Taxane score
timeFrame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
measure: FACT-G score
timeFrame: During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
measure: FACT-Ntx score
timeFrame: 3 months, 6 months, and 12 months after chemotherapy
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Zhenzhen Liu
role: PRINCIPAL_INVESTIGATOR
References: