Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01953159
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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01953159
Study Brief:
Protocol Section:
NCT01953159