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

Temple University Health System (TUHS)

Status: Completed

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

Treatments: Other: questionnaire administration; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01982591

P30CA006927 (U.S. NIH Grant/Contract)

NCI-2013-01957 (Registry Identifier)

ERP-BR-059 (Other Identifier)

IRB#10-039

BR-059

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

115 participants in 1 patient group

Ancillary-Correlative (heavy metal and neurotoxicity)

Description:

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.

Treatment:

Other: questionnaire administration

Other: laboratory biomarker analysis