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

NCT ID: NCT03329131

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2020-09-21

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.

Conditions

Peripheral Neuropathies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: DEVICE

An Elasto gel™ frozen (4°C) glove and sock

Interventions

Cryotherapy

An Elasto gel™ frozen (4°C) glove and sock

Intervention Type: DEVICE

Other Intervention Names

Cold therapy; Elasto gel™

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Virginia G. Kaklamani

Clinical Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virginia Kaklamani, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

UT Health Cancer Center

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC20170535H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS #17-0033

Identifier Type: -

Identifier Source: org_study_id