Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

Paclitaxel-induced Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682499
• Other study ID #: IRB/COSA # 079-12
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2012
• Last updated: September 24, 2014
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Paclitaxel-induced Neuropathy

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Comprehensive Cancer Center	New York	New York
United States	Beth Israel Medical Center	New York	New York
United States	St. Luke's Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Medical Center	St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Taxane-related neuropathic pain	Taxane-related neuropathic pain as measured by the Brief Pain Inventory-Short Form (BPI-SF)	2 years	No
Secondary	Measure of cognitive impairment	Measurement of cognitive impairment using FACT-Cog score	2 years	No