- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03329131
Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
January 21, 2023 updated by: The University of Texas Health Science Center at San Antonio
Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- UT Health Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
An Elasto gel™ frozen (4°C) glove and sock
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline to 6 months post chemo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2017
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
September 27, 2017
First Submitted That Met QC Criteria
October 30, 2017
First Posted (Actual)
November 1, 2017
Study Record Updates
Last Update Posted (Estimate)
January 24, 2023
Last Update Submitted That Met QC Criteria
January 21, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTMS #17-0033
- HSC20170535H (Other Identifier: UT Health San Antonio)
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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