Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Neuropathy, Pain, Recurrent Breast Carcinoma, Stage IV Breast Cancer

In brief

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.

Key facts

Study ID

NCT00998738

Run by

Mayo Clinic

People needed

1

Starts

2009-11-01

Expected to finish

2013-01-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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