Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
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Purpose
RATIONALE: 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 more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone. PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Breast Cancer Recurrent Breast Cancer |
Drug: calcium gluconate Drug: magnesium sulfate Other: placebo Other: quality-of-life assessment Other: questionnaire administration Other: laboratory biomarker analysis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study |
- Comparison of chemotherapy-induced peripheral neuropathy between 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 ] [ Designated as safety issue: No ]
- Percentage of patients with grade 2+ and/or grade 3+ neurotoxicity as measured by NCI CTCAE Active Version neuropathy scale [ Designated as safety issue: Yes ]
- Time to onset of grade 2+ and/or grade 3+ neurotoxicity as assessed by NCI CTCAE Active Version [ Designated as safety issue: Yes ]
- Proportion of patients undergoing dose reduction or discontinuing ixabepilone secondary to peripheral neuropathy [ Designated as safety issue: No ]
- Average cumulative ixabepilone dose [ Designated as safety issue: No ]
- Toxicity profile of CaMg [ Designated as safety issue: Yes ]
- Incidence and severity of the acute pain syndrome (APS) [ Time Frame: Over several courses ] [ Designated as safety issue: No ]
- Association between the ixabepilone-APS and eventual chemotherapy-induced neuropathy [ Designated as safety issue: No ]
| Estimated Enrollment: | 188 |
| Study Start Date: | November 2009 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after ixabepilone treatment.
|
Drug: calcium gluconate
Given IV
Other Names:
Drug: magnesium sulfate
Given IV
Other: quality-of-life assessment
Correlative studies
Other Name: quality of life assessment
Other: questionnaire administration
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
|
|
Placebo Comparator: Arm II
Patients receive calcium placebo IV over 30 minutes immediately before and after ixabepilone treatment.
|
Other: placebo
Given IV
Other Name: PLCB
Other: quality-of-life assessment
Correlative studies
Other Name: quality of life assessment
Other: questionnaire administration
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES: I. To compare ixabepilone-induced peripheral neuropathy (sensory) as measured by EORTC QLQ-CIPN20 sensory subscale between CaMg 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 ixabepilone treatment. ARM II: Patients receive calcium placebo IV over 30 minutes immediately before and after ixabepilone treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 UNL
- Serum magnesium =< UNL
- Serum creatinine =< 1.5 x UNL
- Ability to sign informed consent and understand the nature of a placebo-controlled trial
- ECOG Performance Status (PS) of 0, 1, or 2 (this form is on the MCCRC website https:/mccrc.mayo.edu/mccrc/forms/NonProtocolSpecificForms/)
- Ability to complete questionnaire(s) by themselves or with assistance - Life expectancy >= 4 months
- Presence of a central line placed for administration of calcium and magnesium
- Please contact study investigator and/or consult protocol document for specific details on laboratory criteria
Exclusion:
- Pre-existing history of peripheral neuropathy >= grade 2 (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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Charles Loprinzi, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00998738 History of Changes |
| Other Study ID Numbers: | RC08CC, NCI-2009-01229, 08-008811, CA163-195 |
| Study First Received: | October 19, 2009 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Peripheral Nervous System Diseases Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neuromuscular Diseases Nervous System Diseases Calcium, Dietary Magnesium Sulfate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Analgesics |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 23, 2013