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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT03782402
Eligibility Criteria:
Inclusion Criteria:
* 1\) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.
* 2\) Participants must have an ECOG score of 2 or better. Participants must have a score of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria Adverse Events (CTCAE).
* 3\) Able to give informed consent and comply with all study procedures.
Exclusion Criteria:
* 1\) Diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation.
* 2\) Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
* 3\) Subjects taking warfarin.
* 4\) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT03782402
Study Brief:
Protocol Section:
NCT03782402