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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT03566394
Eligibility Criteria:
Inclusion Criteria:
* English-speaking
* Patients must have histologically confirmed, Stage I-III, breast cancer
* Patient is on an 8-cycle adjuvant anthracycline-cyclophosphamide-taxane containing chemotherapy regimen, and will be starting the taxane-containing portion of chemotherapy within 4 weeks of enrollment.
* Patient has not received prior taxane chemotherapy
* ECOG performance status 0 to 2 (on a scale from 0 to 4, with 0 indicating normal activity, 1 symptomatic but ambulatory self-care possible, 2 ambulatory more than 50% of the time, 3 ambulatory 50% of the time or less and nursing care required, and 4 bedridden and possibly requiring hospitalization)
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients on FEC-D, ACTW, DCx4 chemotherapy.
* Metastatic disease
* Patient currently taking gabapentin or pregabalin for other indications prior to initiating chemotherapy
* Patients concomitantly taking other drugs known to influence GABA (e.g. barbituates, benzodiazepines, nonbenzodiazepines, baclofen)
* Patients using selected analgesics (opioids, acetaminophen, aspirin, NSAIDs) in which the dosages have changed in the 2 weeks prior to starting Taxane chemotherapy, or an analgesic medication was discontinued in the last 2 weeks, or a new analgesic medication was started in the last 2 weeks.
* Patients concomitantly using medical marijuana
* Known restricting adverse events or allergy to gabapentin or pregabalin supplements.
* GFR less than 30ml/min
* Myalgia and/or arthralgia unrelated to chemotherapy, or severe pain syndromes, that could confound the results.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03566394
Study Brief:
Protocol Section:
NCT03566394