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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329131
Recruitment Status : Active, not recruiting
First Posted : November 1, 2017
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE November 1, 2017
Last Update Posted Date January 21, 2022
Actual Study Start Date  ICMJE November 13, 2017
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Official Title  ICMJE Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Brief Summary To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Neuropathies
Intervention  ICMJE Device: Cryotherapy
An Elasto gel™ frozen (4°C) glove and sock
Other Names:
  • Cold therapy
  • Elasto gel™
Study Arms  ICMJE 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.
Intervention: Device: Cryotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 1, 2021)
15
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
65
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03329131
Other Study ID Numbers  ICMJE CTMS #17-0033
HSC20170535H ( Other Identifier: UT Health San Antonio )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP