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



Status:Recruiting
Conditions:Breast Cancer, Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - 70
Updated:3/15/2019
Start Date:May 23, 2017
End Date:May 30, 2019
Contact:Barbara Ehlich, PhD
Email:barbara.ehrlich@yale.edu
Phone:203-737-1158

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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 paclitaxelor docetaxel chemotherapy to determine the onset and severity of
chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).

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).

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
New Haven, Connecticut 06510
Phone: 203-737-7059
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New Haven, CT
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