Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients
NCT ID: NCT03872141
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13 participants
OBSERVATIONAL
2017-05-23
2021-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with stage I-III breast cancer
Patients with Stage I-III breast cancer who will receive paclitaxel or docetaxel treatments as part of their standard of care adjuvant or neoadjuvant therapy are eligible for this study.
Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer
Quantitative measures that include additional aspects of peripheral neuropathy, such as pain, thermal allodynia, numbness and tingling are needed. We propose to evaluate several pharmacodynamics biomarkers in patients before and during chemotherapy: changes in nerve conduction velocity and amplitude, quantitative sensory testing (QST), computer based cognitive assessment, and rate of drop-out from treatment. The tests from this list that best correlate with decreased CIPN would be added to EORTC QLQ-CIPN20 scores and will provide an early indication of CIPN and/or CICI.
Interventions
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Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer
Quantitative measures that include additional aspects of peripheral neuropathy, such as pain, thermal allodynia, numbness and tingling are needed. We propose to evaluate several pharmacodynamics biomarkers in patients before and during chemotherapy: changes in nerve conduction velocity and amplitude, quantitative sensory testing (QST), computer based cognitive assessment, and rate of drop-out from treatment. The tests from this list that best correlate with decreased CIPN would be added to EORTC QLQ-CIPN20 scores and will provide an early indication of CIPN and/or CICI.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* prior history of neuropathy or symptoms of numbness or peripheral pain, or prior neurotoxic chemotherapy.
* current symptoms of numbness and neuropathic pain
* treatment for bipolar disease
* treatment or concomitant use of common medications used to treat neuropathic pain, such as amitriptyline, gabapentin, pregabalin, duloxetine, for any indication
* limited English that would preclude understanding and completion of the study questionnaires
* pregnancy
* life expectancy \<12 weeks
18 Years
70 Years
FEMALE
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Barbara Ehrlich, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Smilow Cancer Center
New Haven, Connecticut, United States
Countries
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Other Identifiers
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2000020709
Identifier Type: -
Identifier Source: org_study_id
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