NCT00998738

Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are effective in preventing peripheral neuropathy caused by ixabepilone.

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 (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN)20 sensory subscale between calcium (Ca) Magnesium (Mg) and placebo arms. SECONDARY OBJECTIVES: I. To compare the incidence of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms. II. To compare the times to onset of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms. III. To compare the proportion of patients requiring ixabepilone dose reductions and/or stopping ixabepilone secondary to peripheral neuropathy (sensory) between CaMg and placebo arms. IV. To assess the toxicity of CaMg in this situation. V. To document the incidence and severity of the acute pain syndrome (APS, commonly known as arthralgias/myalgias) induced by ixabepilone. VI. To evaluate whether CaMg will decrease the acute pain syndrome (APS). VII. To evaluate the incidence and characteristics of, and change in, ixabepilone-APS over several cycles. VIII. To evaluate the association between the ixabepilone-APS and eventual chemotherapy-induced neuropathy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration. ARM II: Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration. After completion of study treatment, patients are followed up monthly for 12 months.

Conditions

• Neuropathy
• Pain
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	Calcium Gluconate	Given IV
DRUG	Magnesium Sulfate	Given IV
OTHER	Placebo	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Ixabepilone	Given IV

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-07-01
• Completion: 2013-01-01
• First posted: 2009-10-20
• Last updated: 2016-02-04
• Results posted: 2013-08-29

Locations

1 site across 1 country: United States