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Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

NCT01682499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-09-25

No results posted yet for this study

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.

Conditions

  • Paclitaxel-induced Neuropathy

Interventions

DRUG

calcium gluconate and magnesium sulfate

Intravenous calcium gluconate and magnesium sulfate, 1g each agent in 100 ml D5W over 30 minutes, immediately before and after each dose of paclitaxel

Sponsors & Collaborators

  • St. Luke's-Roosevelt Hospital Center

    collaborator OTHER

  • Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Theresa Shao, MD · Beth Israel Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01682499 on ClinicalTrials.gov