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

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: Completed
• Conditions: Peripheral Neuropathies
• Intervention / Treatment: Device: Cryotherapy

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): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.	Device: Cryotherapy; An Elasto gel™ frozen (4°C) glove and sock; Other Names: Cold therapy; Elasto gel™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of Peripheral Neuropathy During Taxane Chemotherapy	A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing "no pain" and 100mm representing "pain as bad as it could possibly be". The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity.	Change from baseline to 6 months post chemo (up to 14 months)
Evaluate Safety of Cryotherapy Use	Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes	Baseline to 6 months post Cryotherapy (up to 14 months)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Virginia Kaklamani, MD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): September 21, 2020

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 (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• 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