Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Medical Center
• Collaborator: St. Luke's-Roosevelt Hospital Center
• Treatments: Calcium; Calcium, Dietary; Magnesium Sulfate; Taxane

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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