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Lay Description

This is a translational clinical study aiming to develop approaches to process effectively human tissues and identify biomarkers for painful and non-painful chemotherapy-induced peripheral neuropathy (CIPN). This study will involve obtaining two skin biopsies representing affected and non-affected parts of each patient’s limb. Painful and non-painful neuropathies will be determined by a variety of standard approaches implemented by a neurologist Dr. Bhavaraju-Sanka.  

Category

  • Cancers and Other Neoplasms
  • Diagnostic
  • Genetics
  • Breast
IRB Number
20220482HU
NCT Number
NCT # not yet entered

Eligibility

Eligible Ages
18 and over
Eligible Genders
All
Accepts Healthy Volunteers

Inclusion Criteria

  • Histologically confirmed diagnosis of early-stage breast cancer (stage I-III).
  • Has received adjuvant or neo-adjuvant taxane-based chemotherapy within 10-30 days of consent
  • Age > 18 years. There is no upper age limit for participation in this study.
  • Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation.
  • Prior chemotherapies for previous cancers are permitted, except with prior treatments with taxane, vinca alkaloids, gemcitabine, Eribulin, ixabepilone)5
  • All patients will have given signed, informed consent prior to registration
  • Patients must have a performance status of ECOG 0 or 1.

Exclusion Criteria

  • Patients must not have a personal history of peripheral neuropathy (regardless of cause) or chronic pain (such as fibromyalgia) prior to receiving taxane chemotherapy
  • Patient must not have a history of diabetes mellitus.
  • Patient must not have a history of Raynaud’s disease.
  • Patients must not be receiving Gabapentin or Pregabalin at time of consent
  • Patients with partial or complete limb amputations.
  • As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness, or social condition that would limit compliance with study requirements.

Study Design

Arm Groups

Study Contact

Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu

Principal Investigator
Virginia Kaklamani