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

Inclusion Criteria:

• Documentation of disease: Histologic diagnosis of metastatic breast cancer in womenor men

• Prior treatment- No previous exposure to GM1

• Planned administration of paclitaxel, either given weekly, or weekly 3 weeks on/1week off, to patients with metastatic cancer at a dose of 80 mg/m^2

• No planned treatment with concurrent immunotherapy

• Score of 1 (none) and/or 2 (a little) on the six individual European Organizationfor Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)-chemotherapy-induced peripheral neuropathy (CIPN)20 questions that quantify numbness (N), tingling (T), and pain in the fingers/hands and toes/feet (Items #31-36)

• No diagnosis of fibromyalgia

• No history of significant respiratory tract infection and/or infectious diarrheawithin 14 days before registration

• No history of stroke or cerebrovascular accident in the past 6 months prior toregistration

• No history of diagnosed neurologic or psychiatric disorders, including epilepsy ordementia

• For women of childbearing potential, not pregnant and not nursing, because thisstudy involves an investigational agent whose genotoxic, mutagenic and teratogeniceffects 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 beable to speak and/or read English and/or Spanish

• Persons with impaired decision making such that they cannot understand the benefitsor risks of trial participation, per the judgement of the consenting clinician, willnot 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 upperlimit of normal (ULN)

• Total bilirubin =< 1.5 x ULN

• No planned use of duloxetine

• No planned use of cryotherapy, compression therapy, or cryocompression therapy atstudy entry

Exclusion Criteria:

• N/A