Status:
TERMINATED
Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuropathy
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial studies calcium and magnesium to see how well they work in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving calcium togethe...
Detailed Description
PRIMARY OBJECTIVES: I. To compare ixabepilone-induced peripheral neuropathy (sensory) as measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire (...
Eligibility Criteria
Inclusion
- Scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease
- Serum calcium =\< 1.2 x upper normal limit (UNL)
- Serum magnesium =\< UNL
- Serum creatinine =\< 1.5 x UNL
- Ability to sign informed consent and understand the nature of a placebo-controlled trial
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
- Ability to complete questionnaire(s) by themselves or with assistance
- Life expectancy \>= 4 months
- Presence of a central line
Exclusion
- Pre-existing history of peripheral neuropathy \>= grade 2 (National Cancer Institute \[NCI\] CTCAE Active Version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
- Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy
- Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
- Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential (per physician judgment)
- Diagnosed diabetes requiring insulin or oral hypoglycemic medications
- Receiving digoxin or digitoxin
- History of heart block (any degree)
- Current treatment for arrhythmias
- Concurrent treatment with other neuropathic chemotherapy agents
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00998738
Start Date
November 1 2009
End Date
January 1 2013
Last Update
February 4 2016
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905