Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment with Paclitaxel

Inclusion Criteria

• Documentation of disease: Histologic diagnosis of metastatic breast cancer in women or men
• Prior treatment- No previous exposure to GM1
• Planned or current administration of paclitaxel, either given weekly, or weekly 3 weeks on/1 week off, to patients with metastatic cancer at a dose of 80 mg/m^2 * Patients may have received up to 3 doses of weekly paclitaxel prior to enrollment to be eligible
• No planned treatment with concurrent immunotherapy. Patients who plan to receive trastuzumab and/or pertuzumab along with weekly paclitaxel are eligible
• Score of 1 (none) and/or 2 (a little) on the six individual European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 questions that quantify numbness (N), tingling (T), and pain in the fingers/hands and toes/feet (Items #31-36)
• No history of non-infectious inflammatory lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at the time of study enrollment
• No lung-specific intercurrent clinically significant illnesses including, any underlying pulmonary disorder, such as: * Pulmonary emboli within three months prior to study randomization, * Severe asthma, * Severe chronic obstructive pulmonary disorder (COPD), * Restrictive lung disease, * Significant pleural effusion etc. * Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc.), or * Prior complete pneumonectomy
• Resting saturation of peripheral oxygen (SpO2) ≥ 92%, without supplemental oxygen
• No diagnosis of fibromyalgia
• No history of significant respiratory tract infection and/or infectious diarrhea within 14 days before registration
• No history of stroke or cerebrovascular accident in the past 6 months prior to registration
• No history of diagnosed neurologic or psychiatric disorders, including epilepsy or dementia
• For women of childbearing potential, not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential, a negative pregnancy test done =< 7 days prior to registration is required. Of note, a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Ability to complete questionnaires by themselves or with assistance
• In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English and/or Spanish
• Persons with impaired decision making such that they cannot understand the benefits or risks of trial participation, per the judgement of the consenting clinician, will not be eligible
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) >= 1,000/mm^3
• Platelet count >= 100,000/mm^3
• Creatinine =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• Total bilirubin =< 1.5 x ULN
• No planned use of duloxetine
• No planned use of cryotherapy, compression therapy, or cryocompression therapy at study entry
• Immunosuppressive medication: Patients with prior use of immunosuppressive medication within 14 days prior to randomization are not eligible. Intranasal and inhaled corticosteroids or systemic corticosteroids at doses less than 10 mg/day of prednisone/prednisolone or equivalent are allowed. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents or chemotherapy infusions or for prevention of nausea are also allowed