Purpose

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

IRB Number
20220482HU
NCT Number
-
Open to Enrollment
Yes
Sponsor
-



Study Contact

Principal Investigator
Virginia Kaklamani

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

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Leticia De Los Santos
(210) 450-1437
delossantos@uthscsa.edu

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

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@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



Eligibility

Eligible Ages
18 and over
Eligible Genders
All
Accepts Healthy Volunteers
No

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