Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer

Conditions
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Paclitaxel-induced Neuropathy

Intervention / Treatment
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* Drug: calcium gluconate and magnesium sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium and Magnesium Infusion<br> | Drug: calcium gluconate and magnesium sulfate<br>* Intravenous calcium gluconate and magnesium sulfate, 1g each agent in 100 ml D5W over 30 minutes, immediately before and after each dose of paclitaxel<br>* Other names: Magnesium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess paclitaxel-related neuropathy (grade 2 or greater) | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other measures of neuropathy and quality of life | The secondary endpoints will include other measures of neuropathy and quality of life such as the FACT-TAX score | 2 years | 
| Taxane-related neuropathic pain | Taxane-related neuropathic pain as measured by the Brief Pain Inventory-Short Form (BPI-SF) | 2 years | 
| Measure of cognitive impairment | Measurement of cognitive impairment using FACT-Cog score | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy, taxane, paclitaxel, calcium, magnesium, prevention