Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuropathy | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Recurrent Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium Gluconate | Drug | — | UNRESOLVED |
| Ixabepilone | Drug | — | UNRESOLVED |
| Magnesium Sulfate | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (calcium gluconate, magnesium sulfate)
- description
- Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.
- interventionNames
- Drug: Calcium Gluconate
- Drug: Magnesium Sulfate
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Ixabepilone
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.
- interventionNames
- Other: Placebo
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Ixabepilone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available