Assessment of Paclitaxel-Induced Neuropathy

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer, Breast Cancer, Ovarian Cancer

Intervention / Treatment
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* Other: Blood Collection
* Other: Patient Questionnaires


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with severe neuropathy<br>Patients with severe neuropathy after treatment with paclitaxel. Blood samples and patient questionnaires will be collected. | Other: Blood Collection<br> <br> Other: Patient Questionnaires<br> <br> |
| Patients without neuropathy<br>Patients will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age (within 10 years), tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity | Other: Blood Collection<br> <br> Other: Patient Questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |