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


Phase 1
21 Years
N/A
Open (Enrolling)
Both
Paclitaxel-induced Neuropathy

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

to assess paclitaxel-related neuropathy (grade 2 or greater)

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Theresa Shao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Medical Center

Authority:

United States: Institutional Review Board

Study ID:

IRB/COSA # 079-12

NCT ID:

NCT01682499

Start Date:

August 2012

Completion Date:

August 2014

Related Keywords:

  • Paclitaxel-induced Neuropathy
  • neuropathy
  • taxane
  • paclitaxel
  • calcium
  • magnesium
  • prevention
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location

Beth Israel Medical CenterNew York, New York  10003
St. Luke's Roosevelt Hospital CenterNew York, New York  10019
Beth Israel Comprehensive Cancer CenterNew York, New York