Clinical Trials

Inclusion:

• Scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease
• Serum calcium ≤ 1.2 x UNL
• Serum magnesium ≤ UNL
• Serum creatinine ≤ 1.5 x UNL
• Ability to sign informed consent and understand the nature of a placebo-controlled trial
• ECOG Performance Status (PS) of 0, 1, or 2 (this form is on the Mayo Clinic Cancer Research Consortium (MCCRC) website https:/mccrc.mayo.edu/mccrc/forms/NonProtocolSpecificForms/)
• Ability to complete questionnaire(s) by themselves or with assistance - Life expectancy ≥ 4 months
• Presence of a central line placed for administration of calcium and magnesium
• Please contact study investigator and/or consult protocol document for specific details on laboratory criteria

Exclusion:

• Pre-existing history of peripheral neuropathy ≥ grade 2 (NCI CTCAE Active Version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
• Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy
• Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
• Any of the following: Pregnant women; Nursing women; Women of childbearing potential (per physician judgment)
• Diagnosed diabetes requiring insulin or oral hypoglycemic medications - Receiving digoxin or digitoxin
• History of heart block (any degree)
• Current treatment for arrhythmias
• Concurrent treatment with other neuropathic chemotherapy agents