Print

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
ct.gov registration not required
Open to Enrollment
Yes

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

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Leticia De Los Santos
(210) 450-1437
delossantos@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu

Principal Investigator
Virginia Kaklamani