Lay Description

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


  • Nervous System
  • Cancers and Other Neoplasms
  • Breast
IRB Number
NCT Number
Open to Enrollment


Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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

Arm Groups

Study Contact

Frances Crawford
(210) 450-5037

Sonia Creighton
(210) 450-1366

Virginia Kaklamani
(210) 450-3838

Jo Meekins
(210) 450-1000

Myrna Montenegro
(210) 450-5954

Courtney Nichols
(210) 450-1794

Mailbox Ctrc Regulatory Affairs

Regulatory Staff

Kathleen Rodriguez
(210) 450-1365

Benjamin Schleif
(210) 450-1366

Morgan Seekatz
(210) 450-1133

Principal Investigator
Virginia Kaklamani