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

Primary Purpose

Early Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
monosialic gangliosides
Placebo
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

monosialic ganglioside

Placebo

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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

Full Information

First Posted
August 30, 2020
Last Updated
November 19, 2022
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04538833
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
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
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
monosialic ganglioside
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel application, (placebo as a single infusion)
Intervention Type
Drug
Intervention Name(s)
monosialic gangliosides
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion)
Primary Outcome Measure Information:
Title
FACT-Ntx score
Description
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
Time Frame
2 weeks after chemotherapy
Secondary Outcome Measure Information:
Title
CTCAE Version 4.0 score
Description
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
Time Frame
During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
Title
FACT-Taxane score
Description
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.
Time Frame
During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
Title
FACT-G score
Description
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
Time Frame
During chemotherapy, and 2 weeks, 3 months, 6 months, and 12 months after chemotherapy
Title
FACT-Ntx score
Description
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
Time Frame
3 months, 6 months, and 12 months after chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenzhen Liu
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

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

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