Clinical trial NCT01982591: Heavy Metal Exposure in Predicting Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
Official title: Assessing Heavy Metal Contributions to Neurotoxicity in Breast Cancer Patients Undergoing Adjuvant or Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-11-13
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer Center

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of heavy metal in blood and urine
timeFrame: 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.
measure: Incidence of high grade neurotoxicity, defined as grade >= 3 peripheral neuropathy, graded according to CTCAE v. 4.0
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Lori Goldstein
role: PRINCIPAL_INVESTIGATOR
References: