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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01229 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RC08CC | Other Identifier | Mayo Clinic | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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lack of accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (calcium gluconate, magnesium sulfate) | Experimental | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Gluconate | Drug | Given IV |
|
| 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 | 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. | During the first 18 weeks of ixabepilone-based therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale | Up to 12 months from initiation of ixabepilone | |
| Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Charles Loprinzi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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One participant was recruited between November 2009 and July 2010 at Mayo Clinic. This trial was terminated in July 2010 due to lack of accrual. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Magnesium Sulfate | Drug | Given IV |
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| Placebo | Other | Given IV |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Ixabepilone | Drug | Given IV |
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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.
| Up to 12 months from initiation of ixabepilone |
| Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy | Up to 12 months from initiation of ixabepilone |
| Average Cumulative Ixabepilone Dose | Up to 12 months from initiation of ixabepilone |
| Toxicity Profile of CaMg Per CTCAE Active Version | Up to 12 months from initiation of ixabepilone |
| Incidence of the Acute Pain Syndrome (APS) | 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) |
| Severity of the Acute Pain Syndrome (APS) | 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) |
| Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy | 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. | First cycle of therapy (up to 21 days) |
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| NOT COMPLETED |
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Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years | ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20 | 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. | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | During the first 18 weeks of ixabepilone-based therapy |
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| Secondary | Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | Up to 12 months from initiation of ixabepilone |
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| Secondary | Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version | 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. | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | Up to 12 months from initiation of ixabepilone |
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| Secondary | Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | Up to 12 months from initiation of ixabepilone |
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| Secondary | Average Cumulative Ixabepilone Dose | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | Up to 12 months from initiation of ixabepilone |
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| Secondary | Toxicity Profile of CaMg Per CTCAE Active Version | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | Up to 12 months from initiation of ixabepilone |
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| Secondary | Incidence of the Acute Pain Syndrome (APS) | 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. | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | Treatment initiation to day 21 (Cycle 1) |
|
| |||||||||||||||||||
| Secondary | Severity of the Acute Pain Syndrome (APS) | 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. | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | Treatment initiation to day 21 (Cycle 1) |
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| |||||||||||||||||||
| Secondary | Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy | 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. | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | First cycle of therapy (up to 21 days) |
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Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Loprinzi | Mayo Clinic | 507-266-6247 | cloprinzi@mayo.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002125 | Calcium Gluconate |
| D002118 | Calcium |
| D008278 | Magnesium Sulfate |
| C430592 | ixabepilone |
| ID | Term |
|---|---|
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D017616 | Magnesium Compounds |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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