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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT05689359
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
* Age ≥ 21 years old
* No prior neurotoxic chemotherapies
* No other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum)
* Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
* Be able to undergo MR Imaging
* Be willing to comply with scheduled visits, treatment plan, and MR imaging
* Adequate organ function as defined as:
Hematologic:
Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL
Hepatic:
Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
Renal:
Estimated creatinine clearance (CrCl)≥ 50 mL/min by Cockcroft-Gault formula
Exclusion Criteria:
* Stage IV cancer
* CTCAE neurological function \> grade 1 at baseline
* Mental limitation that precludes understanding of or completion of questionnaires
* History of diabetes or other neurological disorders
* Preexisting peripheral neuropathy
* Prior exposure to neurotoxic chemotherapy
* Currently taking medication to treat or prevent neuropathy
* Have non-MRI compatible metallic objects on/in body
* Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
* Pregnant or lactating patients. Women of childbearing potential and sexually active men must use an effective contraception method during rreatment and for three months after completing treatment. Patients of childbearing potential must have a negative serum or urine B-hCG pregnancy test at screening.
* History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity) or macular degeneration.
* QTc prolongation defined as a QTcF \> 500 ms
* Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT05689359
Study Brief:
Protocol Section:
NCT05689359