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

NCT04538833 | Withdrawn Phase 2

• 1 other identifier: HNCH-BC007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• CTCAE Version 4.0 score

  During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy

• FACT-Taxane score

  During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy

• FACT-G score

  During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy

• FACT-Ntx score

  3 months, 6 months, and 12 months after chemotherapy

Study Arms (2)

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)

Drug: monosialic gangliosides

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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).

monosialic ganglioside

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2×ULN; blood urea nitrogen (BUN) and creatinine (CR) below 1.5 × ULN;
• FACT-Ntx score is 44 points before the adjuvant / neoadjuvant chemotherapy was given;
• Sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 4, 2020
• Study Start: September 9, 2020
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

CN (1)