Purpose

To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities

Category

IRB Number
20170535HU
NCT Number
NCT03329131
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Principal Investigator
Virginia Kaklamani

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
Virginia Kaklamani
(210) 450-3838
kaklamani@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
Regulatory Staff
regaffstaff@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



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    • Histologically confirmed diagnosis of early stage breast cancer (stage I-III).
    • Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy.
    • 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 are permitted, except with prior treatments with taxanes, vinca alcaloids, gemcitabine, eribulin, ixabepilone, platinum drugs)
    • 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 received any prior taxane or platinum based chemotherapy.
    • Patients must not have a history of peripheral neuropathy (regardless of cause).
    • Patient must not have a history of Raynaud's disease.
    • Patients with partial or complete limb amputations.
    • Known hypersensitivity to cold
    • Patient cannot be on the following medications: GABA analogues (such as Neurontin, lyrica), tricyclic antidepressants (such as amitriptyline or nortriptyline)
    • As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirements.
    • Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participant in the clinical trial
    • Must not be pregnant or breast feeding

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Condition
  • Peripheral Neuropathies
  • Arm Groups

    ArmDescriptionIntervention
    Experimental

    Cryotherapy

    Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.
  • Device: Cryotherapy

    An Elasto gel™ frozen (4°C) glove and sock

    Other names:

    • Cold therapy
    • Elasto gel™