Back to resultsBreast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Primary Purpose
Peripheral Neuropathies
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathies
Eligibility Criteria
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
Sites / Locations
- UT Health Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cryotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Prevention of peripheral neuropathy during taxane chemotherapy
Subjects will be asked to complete sensory questionnaires
Secondary Outcome Measures
Full Information
NCT ID
NCT03329131
First Posted
September 27, 2017
Last Updated
January 21, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT03329131
Brief Title
Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Official Title
Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Cold therapy, Elasto gel™
Intervention Description
An Elasto gel™ frozen (4°C) glove and sock
Primary Outcome Measure Information:
Title
Prevention of peripheral neuropathy during taxane chemotherapy
Description
Subjects will be asked to complete sensory questionnaires
Time Frame
Change from baseline to 6 months post chemo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UT Health Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
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