Breast Cancer Clinical Trial

Assessment of Paclitaxel-Induced Neuropathy

Summary

The purpose of this study is to collect clinical data, blood samples, and self reported symptoms from patients that experience unusually severe neuropathy after treatment with paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood samples will be used to create induced pluripotent stem (iPS) cells and eventually artificial nerve cells to be used to study neuropathy in the lab.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria (Severe Toxicity Group):

Diagnosis of cancer (including, but not limited to, breast and ovarian cancer)
Females aged 18 and older
History of grade 3 or higher peripheral neurotoxicity, any neuromotor, neurocortical, or neurocerebellar toxicity, myalgias or arthralgias refractory to non-steroidal anti-inflammatory drugs and steroids, ong-term persistence (> 6 months) of grade 2 or higher peripheral neuropathy, or other unusually severe neurotoxicity approved for inclusion in study by Principal Investigator after completion of paclitaxel chemotherapy regimen or history of peripheral neuropathy that required treatment with narcotics or grade 2 or higher peripheral neuropathy after only 1 to 2 doses of paclitaxel.

Inclusion Criteria (Control Group):

History of no neurotoxicity (grade 0) after completion of a standard paclitaxel-containing chemotherapy regimen
Females age 18 and older
Matched to a specified subject with neurotoxicity based on age (within 10 years), tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity

Exclusion Criteria :

Treatment with other severely neurotoxic chemotherapy (i.e. cisplatin) prior to or concomitantly with paclitaxel. Carboplatin therapy is allowed.
Presence of peripheral neuropathy prior to paclitaxel therapy
Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)

Study is for people with:

Breast Cancer

Estimated Enrollment:

43

Study ID:

NCT01953159

Recruitment Status:

Active, not recruiting

Sponsor:

University of Chicago

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There is 1 Location for this study

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University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

43

Study ID:

NCT01953159

Recruitment Status:

Active, not recruiting

Sponsor:


University of Chicago

How clear is this clinincal trial information?

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