Clinical trial NCT01682499: Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy
Official title: Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Paclitaxel-induced Neuropathy
Keywords: neuropathy
taxane
paclitaxel
calcium
magnesium
prevention
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
Collaborators: name: St. Luke's-Roosevelt Hospital Center
First posted: 2012-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: to assess paclitaxel-related neuropathy (grade 2 or greater)
timeFrame: 2 years
Secondary outcomes:
measure: Other measures of neuropathy and quality of life
timeFrame: 2 years
measure: Taxane-related neuropathic pain
timeFrame: 2 years
measure: Measure of cognitive impairment
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Theresa Shao, MD
role: PRINCIPAL_INVESTIGATOR
References: