NCT03872141

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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).

Detailed description

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 or 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

Type	Name	Description
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.

Timeline

• Start date: 2017-05-23
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2019-03-13
• Last updated: 2021-05-03

Locations

1 site across 1 country: United States