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Trial Title:
A Multicenter, Randomized, Double-blind Phase II Trial to Evaluate GM1 Prevention of Peripheral Neuropathy in Patients With Breast Cancer
NCT ID:
NCT05802342
Condition:
To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer Patients
Conditions: Official terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group.
The treatment plan was as follows.
Group A: GM1 (100 mg) + albumin paclitaxel; Group B: GM1 (400 mg) + albumin paclitaxel;
Group C: placebo + albumin paclitaxel;
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Monosialotetrahexose ganglioside sodium injection
Description:
The treatment period was GM1/ placebo with albumin-paclitaxel from cycle 1 to cycle 4/6.
The treatment period was GM1/ placebo with albumin-paclitaxel. GM1/ placebo was
administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before
administration (D0), on the day of administration (D1) and on the day after
administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day
1, with a total of 4/6 cycles of administration. GM1/ placebo was administered every 2
weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the
day of administration (D1) and on the day after administration (D2), and
albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6
cycles of administration.
Arm group label:
A
Arm group label:
B
Arm group label:
C
Summary:
This randomized, double-blind, multicenter, placebo-controlled Phase II trial was
designed to investigate the efficacy and safety of GM1 in the prevention of peripheral
neuropathy caused by albumin-bound paclitaxel regimen in breast cancer patients.This
study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group Subjects
received study treatment until the end of treatment for a total of 4/6 cycles. The
treatment period was GM1/ placebo combined with albumin-bound paclitaxel therapy. GM1 /
placebo was administered 1 day before administration (D0), on the day of administration
(D1) and on the day after administration (D2), and albumin-bound paclitaxel was
administered starting on day D1, with a total of 4/6 cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Fully understand the content of the experiment and voluntarily sign the informed
consent;
2. Age from 18 to 75 years old (including both ends);
3. Breast cancer patients who provide definitive histological and/or cytological
diagnosis of breast cancer and are proposing adjuvant/neoadjuvant therapy with the
albumin-paclitaxel regimen;
4. ECOG score 0~1;
5. The organ function level must meet the requirements
6. Subjects (both male and female) agreed to use effective contraception from the time
of signing the informed consent to 30 days after the last use of the study drug.
Female subjects of childbearing age cannot be pregnant or lactating.
7. Patients can accurately record or express the occurrence and severity of
neurotoxicity in questionnaires;
8. After enrollment, patients should not receive other treatments or care that might
prevent or treat neurotoxic adverse events
Exclusion Criteria:
1. Presence of grade 1 peripheral neurotoxicity (CTCAE≥1) or symptoms of peripheral
neuropathy (FACT/GOG-Ntx≥1)
2. There are risk factors for peripheral neuropathy (except peripheral neuropathy
caused by chemotherapy),Including but not limited to: diabetic peripheral
neuropathy; Peripheral vascular disease; Folic acid, B12 vitamin deficiency;
Postoperative neuropathy; Post-traumatic neuropathy; Peripheral neuroinflammatory
lesions; Peripheral neuropathy caused by tumor compression and infiltration; Other
researchers believe that can cause limb pain, numbness, paresthesia, dysfunction of
the skin, muscle, vascular diseases;
3. Cardiovascular and cerebrovascular diseases, including but not limited to:
Myocardial infarction (within 6 months before signing the informed consent),
unstable angina, high risk of uncontrollable arrhythmia, coronary artery bypass
grafting, cerebrovascular accident (within 6 months before signing the informed
consent), congestive heart failure (cardiac function grade III-Ⅳ), pulmonary
embolism, deep vein thrombosis, and other cardiovascular and cerebrovascular systems
deemed unsuitable for inclusion by the investigator General disease;
4. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood
pressure ≥100mmHg) after optimal treatment with antihypertensive drugs; Patients
with blood pressure deemed unsuitable for clinical trials by the investigator;
5. Diabetic patients with HBA1c ≥9.0%;
6. Active bacterial, fungal, or viral infections that require systematic treatment
within one week prior to initial administration; Infectious diarrhea occurred within
4 weeks prior to initial administration;
7. History of inherited abnormal glucose and lipid metabolism (ganglioside accumulation
disease, such as familial amaurosis, retinal degeneration) or autoimmune disease;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome (AIDS); Syphilis antibody positive;
9. Active hepatitis B (HBsAg positive with HBV-DNA > 500 IU/ml or lower limit of Center
detection [only when lower limit of Center detection is higher than 500 IU/ml]),
active hepatitis C (patients with HCV antibody positive but HCV-RNA < lower limit of
Center detection are admitted);
10. Known allergy to ganglioside drugs or any excipient component of such products; Or
to treat an allergy to a drug or any excipient component of such product;
11. Patients who, in the judgment of the investigator, may increase the risk associated
with the study, may interfere with the interpretation of the study results, or may
be deemed unsuitable for inclusion by the investigator and/or sponsor.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 20, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802342
