Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
43 participants
OBSERVATIONAL
2013-08-29
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients with severe neuropathy
Patients with severe neuropathy after treatment with paclitaxel. Blood samples and patient questionnaires will be collected.
Blood Collection
Patient Questionnaires
Patients without neuropathy
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
Blood Collection
Patient Questionnaires
Interventions
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Blood Collection
Patient Questionnaires
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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)
18 Years
FEMALE
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Gini Fleming, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB13-0775
Identifier Type: -
Identifier Source: org_study_id
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