Heavy Metal Exposure in Predicting Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

Study Overview
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Brief Summary
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This research trial studies heavy metal exposure in predicting peripheral neuropathy in patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may help doctors find out whether side effects from chemotherapy are related to heavy metal exposure.

Detailed Description
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PRIMARY OBJECTIVES: I. To describe the correlation, if any, of specific heavy metals with high grade symptoms of peripheral neuropathy, defined as grade >= 3 peripheral neuropathy, (utilizing the Common Terminology Criterial for Adverse Events [CTCAE] version [v.] 4.0) in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy. SECONDARY OBJECTIVES: I. To characterize the range of specific heavy metals in a cohort of breast cancer patients undergoing (neo)adjuvant chemotherapy treatment. II. To evaluate the reproducibility of sera and urine testing of heavy metal levels by inductively coupled plasma mass spectrometry (ICP-MS) testing in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy. OUTLINE: Patients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at baseline and at the completion of treatment. Patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment.

Official Title
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Assessing Heavy Metal Contributions to Neurotoxicity in Breast Cancer Patients Undergoing Adjuvant or Neoadjuvant Chemotherapy

Conditions
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Male Breast Cancer, Neurotoxicity, Peripheral Neuropathy, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically confirmed invasive mammary carcinoma; any histologic sub-type allowed Patients must be diagnosed with stage I, II or III breast cancer Patients must be undergoing treatment with an adjuvant or neoadjuvant cytotoxic chemotherapy that includes a taxane, specifically paclitaxel, nab-paclitaxel (Abraxane), or docetaxel Patients may have received prior endocrine and/or radiation therapy Patients must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients who have been previously treated with cytotoxic chemotherapy Patients with pre-existing peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (heavy metal and neurotoxicity)<br>Patients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at baseline and at the completion of treatment. Patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment. | Other: laboratory biomarker analysis<br>* Correlative studies<br>Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of heavy metal in blood and urine | Heavy metal levels will be characterized in participants being treated at participating sites. Means and variances and ranges of these levels will be tabulated. | The levels will be measured on a blood and urine sample obtained on the first day of chemotherapy, which is considered the first day of the study. The actual laboratory processing of the samples will occur in batches throughout the duration of the study. | 
| Incidence of high grade neurotoxicity, defined as grade >= 3 peripheral neuropathy, graded according to CTCAE v. 4.0 | Neurotoxicity grade during chemotherapy will be obtained from the medical record and study doctor's notes. The maximum grade during the course of chemotherapy will be recorded. Frequencies of toxicities will be tabulated. | Last day of chemotherapy approx.4-6 months from initiation, depending on chemotherapy regimen. Neurotoxicity grade will be assessed intermittently during course of therapy, with note of maximum grade made by clinician. |