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

The University of Texas System (UT)

Status: Completed

Conditions: Peripheral Neuropathies

Treatments: Device: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03329131

HSC20170535H (Other Identifier)

CTMS #17-0033

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Cryotherapy

Experimental group

Description:

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.

Treatment:

Device: Cryotherapy