Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Condition: Neuropathy; Pain; Recurrent Breast Carcinoma; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases
Intervention: Calcium Gluconate; Magnesium Sulfate; Placebo; Quality-of-Life Assessment; Questionnaire Administration; Ixabepilone
Intervention description: Given IV; Given IV; Given IV; Ancillary studies; Ancillary studies; Given IV
Intervention MeSH terms: Calcium, Dietary; Magnesium Sulfate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies calcium and magnesium to see how well they work in
      preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving
      calcium together with magnesium may stop or delay the development of peripheral neuropathy in
      patients with cancer who are receiving treatment with ixabepilone. It is not yet known
      whether calcium and magnesium are effective in preventing peripheral neuropathy caused by
      ixabepilone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 upper normal limit (UNL)

          -  Serum magnesium =< UNL

          -  Serum creatinine =< 1.5 x UNL

          -  Ability to sign informed consent and understand the nature of a placebo-controlled
             trial

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Life expectancy >= 4 months

          -  Presence of a central line

        Exclusion Criteria:

          -  Pre-existing history of peripheral neuropathy >= grade 2 (National Cancer Institute
             [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