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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 Mayo Clinic Cancer Research Consortium (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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20453011

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