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

Completed

Conditions studied: Breast Cancer, Chemotherapy Induced Peripheral Neuropathy, Paclitaxel Induced Neuropathy

In brief

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).

Key facts

Study ID

NCT03872141

Run by

Yale University

People needed

13

Starts

2017-05-23

Expected to finish

2021-02-25

Last updated by the study team

2021-05-03

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Smilow Cancer Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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