Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

Completed · Phase 1

Conditions studied: Paclitaxel-induced Neuropathy

In brief

This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg) infusion for prevention of taxane induced neuropathy in patients with early stage breast cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles or every week for 12 weeks.

Key facts

Study ID

NCT01682499

Run by

Beth Israel Medical Center

People needed

50

Starts

2012-08-01

Expected to finish

2014-08-01

Last updated by the study team

2014-09-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 21 years
• History of stage I-III breast cancer
• Patient scheduled to be receiving adjuvant or neo-adjuvant paclitaxel given every week for 12 weeks or given every two weeks for 4 cycles
• Serum magnesium level ≤ UNL
• Serum calcium level ≤ UNL
• Serum creatinine ≤ 1.5 x UNL
• Signed informed consent

You may not qualify if…

• Pre-existing peripheral neuropathy of any grade
• Current treatment for arrhythmias
• Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic medications such as carbamazepine, phenytoin, gabapentin, lamotrigine, or concurrent treatment with other neuropathic chemotherapy agents
• Current narcotic use

Where it is running

• Beth Israel Medical Center — New York, New York, United States
• Beth Israel Comprehensive Cancer Center — New York, New York, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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