- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (calcium gluconate, magnesium sulfate)
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
|
Ancillary studies
Other Names:
Ancillary studies
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
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Placebo Comparator: Arm II (placebo)
Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.
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Ancillary studies
Other Names:
Ancillary studies
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20
Time Frame: During the first 18 weeks of ixabepilone-based therapy
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.
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During the first 18 weeks of ixabepilone-based therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale
Time Frame: Up to 12 months from initiation of ixabepilone
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Up to 12 months from initiation of ixabepilone
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Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version
Time Frame: Up to 12 months from initiation of ixabepilone
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Time to onset of grade 2+ neurotoxicity was defined as time from randomization to the first occurrence of grade 2+ neurotoxicity.
Time to onset of grade 3+ neurotoxicity was defined as time from randomization to the first occurrence of grade 3+ neurotoxicity.
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Up to 12 months from initiation of ixabepilone
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Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy
Time Frame: Up to 12 months from initiation of ixabepilone
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Up to 12 months from initiation of ixabepilone
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Average Cumulative Ixabepilone Dose
Time Frame: Up to 12 months from initiation of ixabepilone
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Up to 12 months from initiation of ixabepilone
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Toxicity Profile of CaMg Per CTCAE Active Version
Time Frame: Up to 12 months from initiation of ixabepilone
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Up to 12 months from initiation of ixabepilone
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Incidence of the Acute Pain Syndrome (APS)
Time Frame: Treatment initiation to day 21 (Cycle 1)
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APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be. The outcome measures for each subsequent cycle will be analyzed in a similar fashion. |
Treatment initiation to day 21 (Cycle 1)
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Severity of the Acute Pain Syndrome (APS)
Time Frame: Treatment initiation to day 21 (Cycle 1)
|
APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be. The outcome measures for each subsequent cycle will be analyzed in a similar fashion. |
Treatment initiation to day 21 (Cycle 1)
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Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy
Time Frame: First cycle of therapy (up to 21 days)
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Correlation coefficients will be produced relating the worst pain scores in the first cycle of therapy and the subsequent neuropathy scores as judged from the daily and weekly questions.
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First cycle of therapy (up to 21 days)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Neuromuscular Diseases
- Breast Neoplasms
- Peripheral Nervous System Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Calcium
- Calcium, Dietary
- Magnesium Sulfate
Other Study ID Numbers
- RC08CC (Other Identifier: Mayo Clinic)
- P30CA015083 (U.S. NIH Grant/Contract)
- NCI-2009-01229 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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