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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01982591
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : June 15, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
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 Other: laboratory biomarker analysis Other: questionnaire administration

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.

Study Design
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Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Heavy Metal Contributions to Neurotoxicity in Breast Cancer Patients Undergoing Adjuvant or Neoadjuvant Chemotherapy
Actual Study Start Date : January 3, 2011
Actual Primary Completion Date : March 24, 2015
Actual Study Completion Date : March 24, 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Ancillary-Correlative (heavy metal and neurotoxicity)
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
Correlative studies

Other: questionnaire administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Level of heavy metal in blood and urine [ Time Frame: 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. ]
    Heavy metal levels will be characterized in participants being treated at participating sites. Means and variances and ranges of these levels will be tabulated.

  2. Incidence of high grade neurotoxicity, defined as grade >= 3 peripheral neuropathy, graded according to CTCAE v. 4.0 [ Time Frame: 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. ]
    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.


Biospecimen Retention:   Samples Without DNA
Whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer Center
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982591


Locations
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United States, Pennsylvania
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lori Goldstein Fox Chase Cancer Center
More Information
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01982591    
Other Study ID Numbers: ERP-BR-059
NCI-2013-01957 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB#10-039
BR-059
ERP-BR-059 ( Other Identifier: Fox Chase Cancer Center )
P30CA006927 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Neoplasms, Male
Peripheral Nervous System Diseases
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders