Status:
COMPLETED
Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients
Lead Sponsor:
Yale University
Conditions:
Breast Cancer
Chemotherapy Induced Peripheral Neuropathy
Eligibility:
FEMALE
18-70 years
Brief 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 doce...
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 d...
Eligibility Criteria
Inclusion
- Women ages 18 to 70 with histologically confirmed clinically stage I-III breast cancer who will receive weekly paclitaxel (80 mg/m2) or docetaxel (60-100mg/m2) chemotherapy as part of their routine care.
Exclusion
- diabetes mellitus
- 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
- participation in other research studies either concurrent with or within 30 days prior to participation in this study may be an exclusion criteria
Key Trial Info
Start Date :
May 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 25 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03872141
Start Date
May 23 2017
End Date
February 25 2021
Last Update
May 3 2021
Active Locations (1)
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1
Smilow Cancer Center
New Haven, Connecticut, United States, 06510