Breast Cancer Clinical Trial

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

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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).

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Full 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).

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

13

Study ID:

NCT03872141

Recruitment Status:

Completed

Sponsor:

Yale University

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There is 1 Location for this study

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Smilow Cancer Center
New Haven Connecticut, 06510, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

13

Study ID:

NCT03872141

Recruitment Status:

Completed

Sponsor:


Yale University

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials for Breast Cancer
Have You Been Diagnosed With Late-Stage Breast Cancer? Know That You Have Treatment Options.
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