A Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity

NCT04222790 | Completed Phase 2

• 1 other identifier: HELEN-004
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Taxane-induced peripheral neuropathy (TIPN) caused by 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)

• Functional Assessment of Cancer Treatment Neurotoxicity Scale （FACT-Ntx）score

  FACT-Ntx scale score 2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy. (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). The scale is graded 0-4. A low score indicates a good effect.

  2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy

Secondary Outcomes (4)

• CTCAE Version 4.0 score

  1 month Day 1 of Week 1 to 1 year after the last course of chemotherapy

• Functional Assessment of Cancer Treatment Neurotoxicity Scale （FACT-Ntx）score

  3 months, 6 months, and 12 months after 4 cycles of chemotherapy

• functional assesment of cancer therapy-taxane （FACT-Taxane）score

  2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy

• Functional Assessment of Cancer Therapy-General （FACT-G）score

  2 weeks after 4 cycles of albumin-bound paclitaxel chemotherapy

Study Arms (2)

monosialic ganglioside

EXPERIMENTAL

On the days -1, 1, and 2 of albumin 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 paclitaxel (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 paclitaxel (GM1 is a single infusion).

Also known as: experience group

monosialic ganglioside

Placebo OTHER

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

Also known as: control group

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
• It is expected that the standard chemotherapy regimen containing albumin paclitaxel will be used in the adjuvant / neo-adjuvant chemotherapy regimen. The standard scheme includes: a. Albumin paclitaxel adopts a single-week regimen, 125-150mg / m2 for 12 weeks; b. Albumin paclitaxel Take a 3-week regimen, 260 mg / m2, for a total of 4 cycles. The plan must not contain platinum and other types of purple shirt drugs;
• 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 109 / L; platelet (PLT) ≥ 90x109 / 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 in the screening period
• Sign the informed consent.

You may not qualify if:

• There are any toxic events of the peripheral nervous system before enrollment, including: FACT-Ntx subscale score \<44; ≥ 1 level of peripheral toxicity according to the CTCAE version 4.0 scale; all other pathological symptoms or diseases may affect Assessment of adverse neurotoxic effects;
• 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

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  STUDY DIRECTOR

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: January 7, 2020
• First Posted: January 10, 2020
• Study Start: August 28, 2020
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

CN (1)