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Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

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ClinicalTrials.gov Identifier: NCT01682499
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center

Tracking Information
First Submitted Date  ICMJE August 21, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
to assess paclitaxel-related neuropathy (grade 2 or greater) [ Time Frame: 2 years ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01682499 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • Other measures of neuropathy and quality of life [ Time Frame: 2 years ]
    The secondary endpoints will include other measures of neuropathy and quality of life such as the FACT-TAX score
  • Taxane-related neuropathic pain [ Time Frame: 2 years ]
    Taxane-related neuropathic pain as measured by the Brief Pain Inventory-Short Form (BPI-SF)
  • Measure of cognitive impairment [ Time Frame: 2 years ]
    Measurement of cognitive impairment using FACT-Cog score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy
Official Title  ICMJE Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Paclitaxel-induced Neuropathy
Intervention  ICMJE 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
Other Names:
  • Ca
  • Mg
  • Calcium
  • Magnesium
Study Arms  ICMJE Experimental: Calcium and Magnesium Infusion
Intervention: Drug: calcium gluconate and magnesium sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2013)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2012)
40
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01682499
Other Study ID Numbers  ICMJE IRB/COSA # 079-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beth Israel Medical Center
Study Sponsor  ICMJE Beth Israel Medical Center
Collaborators  ICMJE St. Luke's-Roosevelt Hospital Center
Investigators  ICMJE
Principal Investigator: Theresa Shao, MD Beth Israel Medical Center
PRS Account Beth Israel Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP