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Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients

NCT03872141 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2021-05-03

No results posted yet for this study

Summary

The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).

Conditions

  • Breast Cancer
  • Chemotherapy Induced Peripheral Neuropathy
  • Paclitaxel Induced Neuropathy

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Barbara Ehrlich, PhD · Yale University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2021-02-25
Completion
2021-02-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872141 on ClinicalTrials.gov