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

Primary Purpose

Neuropathy, Pain, Recurrent Breast Carcinoma

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Calcium Gluconate

Magnesium Sulfate

Placebo

Quality-of-Life Assessment

Questionnaire Administration

Ixabepilone

About this trial

This is an interventional supportive care trial for Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (calcium gluconate, magnesium sulfate)

Arm II (placebo)

Arm Description

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.

Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale

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.

Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy

Average Cumulative Ixabepilone Dose

Toxicity Profile of CaMg Per CTCAE Active Version

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.

Severity of the Acute Pain Syndrome (APS)

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.

Full Information

NCT ID

NCT00998738

First Posted

October 19, 2009

Last Updated

January 7, 2016

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00998738

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Terminated

Why Stopped

lack of accrual

Study Start Date

November 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (calcium gluconate, magnesium sulfate)

Arm Type

Experimental

Arm Description

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.

Arm Title

Arm II (placebo)

Arm Type

Placebo Comparator

Arm Description

Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.

Intervention Type

Drug

Intervention Name(s)

Calcium Gluconate

Other Intervention Name(s)

Calcium D-gluconate, Calglucon

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Magnesium Sulfate

Other Intervention Name(s)

Magnesium SO4, Magnesium Sulfate whiskers

Intervention Description

Given IV

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

placebo therapy, PLCB, sham therapy

Intervention Description

Given IV

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Drug

Intervention Name(s)

Ixabepilone

Other Intervention Name(s)

IXEMPRA

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20

Description

Time Frame

During the first 18 weeks of ixabepilone-based therapy

Secondary Outcome Measure Information:

Title

Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale

Time Frame