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Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03329131
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio

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

Condition or disease Intervention/treatment Phase
Peripheral Neuropathies Device: Cryotherapy Not Applicable

Detailed Description:
This is a therapeutic study investigating the use of cryotherapy in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) and associated nail toxicities. The therapeutic intervention will involve patients wearing an Elasto-Gel cold glove and sock on one hand and one foot (both on the right side or both on the left side). The patients will wear the glove and sock during each infusion of taxane chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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™

Primary Outcome Measures :
  1. Prevention of peripheral neuropathy during taxane chemotherapy [ Time Frame: Change from baseline to 6 months post chemo ]
    Subjects will be asked to complete sensory questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03329131

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Contact: Epp Goodwin 210-450-1000

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United States, Texas
UT Health Cancer Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin    210-450-1000      
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio

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Responsible Party: Virginia G. Kaklamani, Clinical Investigator, The University of Texas Health Science Center at San Antonio Identifier: NCT03329131     History of Changes
Other Study ID Numbers: CTMS #17-0033
HSC20170535H ( Other Identifier: UT Health San Antonio )
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases