Heavy Metal Exposure in Predicting Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
Assessing Heavy Metal Contributions to Neurotoxicity in Breast Cancer Patients Undergoing Adjuvant or Neoadjuvant Chemotherapy
5 other identifiers
observational
115
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2015
CompletedJune 15, 2017
June 1, 2017
4.2 years
October 24, 2013
June 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (1)
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.
Interventions
Correlative studies
Ancillary studies
Eligibility Criteria
Cancer Center
You may qualify if:
- 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
You may not qualify if:
- Patients who have been previously treated with cytotoxic chemotherapy
- Patients with pre-existing peripheral neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fox Chase Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Goldstein
Fox Chase Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2013
First Posted
November 13, 2013
Study Start
January 3, 2011
Primary Completion
March 24, 2015
Study Completion
March 24, 2015
Last Updated
June 15, 2017
Record last verified: 2017-06