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

Peripheral Neuropathies Clinical Trial

Official title:

Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03329131
• Other study ID #: CTMS #17-0033
• Secondary ID: HSC20170535H
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathies

Intervention

Device:
• Cryotherapy
An Elasto gel™ frozen (4°C) glove and sock

Locations

Country	Name	City	State
United States	UT Health Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of peripheral neuropathy during taxane chemotherapy	Subjects will be asked to complete sensory questionnaires	Change from baseline to 6 months post chemo