Assessment of Paclitaxel-Induced Neuropathy

Breast Cancer Clinical Trial

Official title:

Validation of a Polygenic Neurotoxicity Risk Score in Patients With Unusually Severe Paclitaxel-Induced Neuropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01953159
• Other study ID #: IRB13-0775
• Status: Active, not recruiting
• Start date: August 29, 2013
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 2025
• Est. primary completion date: May 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Cancer
• Ovarian Cancer

Intervention

Other:
• Blood Collection

• Patient Questionnaires

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of polygenic risk score	Patients will be assessed for neuropathy symptoms and blood samples will be analyzed to detect potential predictive markers	2 years