Clinical trial · Interventional
Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy
Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer
NCT01682499CI-TRIAL-00015703completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg) infusion for prevention of taxane induced neuropathy in patients with early stage breast cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles or every week for 12 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Paclitaxel-induced Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium gluconate and magnesium sulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Calcium and Magnesium Infusion
- interventionNames
- Drug: calcium gluconate and magnesium sulfate
Primary outcomes (1)
- measure
- to assess paclitaxel-related neuropathy (grade 2 or greater)
- timeFrame
- 2 years
- description
- The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater) as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion during paclitaxel chemotherapy and compare it with historical controls
Secondary outcomes (3)
- measure
- Other measures of neuropathy and quality of life
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 21 years * History of stage I-III breast cancer * Patient scheduled to be receiving adjuvant or neo-adjuvant paclitaxel given every week for 12 weeks or given every two weeks for 4 cycles * Serum magnesium level ≤ UNL * Serum calcium level ≤ UNL * Serum creatinine ≤ 1.5 x UNL * Signed informed consent Exclusion Criteria: * Pre-existing peripheral neuropathy of any grade * Current treatment for arrhythmias * Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic medications such as carbamazepine, phenytoin, gabapentin, lamotrigine, or concurrent treatment with other neuropathic chemotherapy agents * Current narcotic use
References
Publications (0)
Data not yet available
No reference posted for this study.