Paclitaxel-induced Neuropathy Clinical Trial
Official title:
Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer
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.
Chemotherapy induced peripheral neuropathy (CIPN) is a major dose limiting side effect of
many cytotoxic chemotherapy, and can be extremely disabling, causing significant loss of
functional abilities. Calcium and magnesium infusions were shown to decreased the incidence
and intensity of neuropathy symptoms related to oxaliplatin.
There are currently no effective drugs or treatment modalities for the prevention or
treatment of taxane related neuropathy. Given the morbidity of taxane induced neuropathy and
the safety of Ca/Mg infusion, it is reasonable to assess the feasibility of this
intervention in woman with stage I-III breast cancer receiving adjuvant or neo-adjuvant
paclitaxel treatment, either given every 2 weeks for 4 cycles or every week for 12 weeks.
Calcium gluconate and magnesium sulfate, 1 g of each agent in 100 ml D5W will be infused
over 30 minutes, immediately before and after each dose of paclitaxel. The Ca/Mg infusion
will be given through the same line used for giving chemotherapy.
The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or
greater) as measured by NCI Common Terminology Criteria Version 3 in patients receiving
Ca/Mg infusion during paclitaxel chemotherapy and compare it with historical controls.
Secondary endpoints will include other measures of neuropathy and quality of life such as
the FACT-Tax score, taxane-related neuropathy pain as measured by the Brief Pain
Inventory-Short Form (BPI-SF), and measure of cognitive impairment using FACT-cog score.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention