Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01682499
First received: August 21, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Paclitaxel-induced Neuropathy
Drug: calcium gluconate and magnesium sulfate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • to assess paclitaxel-related neuropathy (grade 2 or greater) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Other measures of neuropathy and quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Taxane-related neuropathic pain as measured by the Brief Pain Inventory-Short Form (BPI-SF)

  • Measure of cognitive impairment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measurement of cognitive impairment using FACT-Cog score


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium and Magnesium Infusion 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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682499

Locations
United States, New York
Beth Israel Comprehensive Cancer Center
New York, New York, United States, 10011
Beth Israel Medical Center
New York, New York, United States, 10003
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
Beth Israel Medical Center
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Theresa Shao, MD Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01682499     History of Changes
Other Study ID Numbers: IRB/COSA # 079-12
Study First Received: August 21, 2012
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
neuropathy
taxane
paclitaxel
calcium
magnesium
prevention

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Calcium, Dietary
Magnesium Sulfate
Taxane
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014