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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982591
• Other study ID #: ERP-BR-059
• Secondary ID: NCI-2013-01957IR
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: June 14, 2017
• Start date: January 3, 2011
• Est. completion date: March 24, 2015

Study information

• Verified date: June 2017
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 24, 2015
• Est. primary completion date: March 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer
• Neurotoxicity
• Neurotoxicity Syndromes
• Peripheral Nervous System Diseases
• 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

Other:
• laboratory biomarker analysis
Correlative studies
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.