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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT05980169
Eligibility Criteria:
Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible for inclusion in the study:
1. Patients must be age 18 or older.
2. Histologically confirmed gynecologic malignancy.
3. Eastern Cooperative Oncology Group performance status of 0 to 2.
4. Be willing and able to participate in all required evaluations for the protocol
5. Speak, read, and understand English
Cohort A patients must have:
6. Carboplatin and paclitaxel prescribed as first line treatment. Patients may also receive Trastuzumab, Bevacizumab, Pembrolizumab or Dostarlimab in conjunction with carboplatin and paclitaxel as these regimens are standard of care for specific cancers. Additional drugs may be acceptable after review and approval by the PI. In the event of a hypersensitivity reaction with paclitaxel, subjects may be switched to docetaxel and continue on study. In the event of a carboplatin hypersensitivity reaction, additional drugs or alterations to the treatment regimen may be changed after review and approval by the PI.
Cohort B patients must have:
7\. Received prior treatment with a platinum agent and paclitaxel with a persistent CTCAE defined Grade 2 or worse neuropathy
\-
Exclusion Criteria: Patients with any of the following will not be included in the study:
1. Current diagnosis of comorbidity causing neuropathy (including peripheral vascular disease, lupus, Sjogren's syndrome, rheumatoid arthritis). Patients with diabetes may participate if baseline exam is negative for neuropathy symptoms and HbA1c \< 7.
2. Pregnant
3. DVT diagnosed within 4 weeks prior to treatment
4. Body weight greater 195kg
Cohort A patients:
6\. Previous treatment with taxane therapy 7. Preexisting diagnosis of neuropathy 8. Currently prescribed gabapentin, duloxetine or pregabalin
Cohort B patients:
9\. Diagnosis of neuropathy prior to cancer treatment
\-
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05980169
Study Brief:
Protocol Section:
NCT05980169