A Multicenter, Randomized, Double-blind Phase II Trial to Evaluate GM1 Prevention of Peripheral Neuropathy in Patients With Breast Cancer

Launched by QILU PHARMACEUTICAL CO., LTD. · Mar 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a treatment called GM1 can help prevent a painful condition known as peripheral neuropathy in women with breast cancer who are receiving a specific chemotherapy drug called albumin-bound paclitaxel. Peripheral neuropathy can cause symptoms like tingling, numbness, and pain, and this study aims to see if GM1 can reduce these effects. The trial will involve about 150 women aged 18 to 75 who have a confirmed diagnosis of breast cancer and are planning to undergo chemotherapy with albumin-bound paclitaxel.

Participants in the study will be randomly assigned to receive either GM1 or a placebo (a treatment with no active ingredients) during their chemotherapy sessions. They will take the study treatment for a total of 4 to 6 cycles of chemotherapy, starting one day before their chemotherapy, on the day of treatment, and the day after. To be eligible for the trial, participants must be able to understand the study and provide informed consent, have an ECOG score (a measure of how well they can perform daily activities) of 0 or 1, and not have any other conditions that could interfere with the study results. This trial is not yet recruiting participants, but it is an important step in finding better ways to manage side effects of cancer treatment.

Gender

FEMALE

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.