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

NCT03329131 | Completed Results DMC FDA Device

• 2 other identifiers: CTMS #17-0033HSC20170535H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Neuropathies

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Cryotherapy

EXPERIMENTAL

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

Interventions

Cryotherapy DEVICE

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

Also known as: Cold therapy, Elasto gel™

Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health Cancer Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Virginia Kaklamani, MD
• Organization: University of Texas Health Science Center in San Antonio

kaklamani@uthscsa.edu

210-450-3838

Study Officials

• Virginia Kaklamani, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: November 1, 2017
• Study Start: November 13, 2017
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-09

Locations

US (1)