Clinical trial NCT03329131: Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Official title: Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathies
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Prevention of Peripheral Neuropathy During Taxane Chemotherapy
timeFrame: Change from baseline to 6 months post chemo (up to 14 months)
measure: Evaluate Safety of Cryotherapy Use
timeFrame: Baseline to 6 months post Cryotherapy (up to 14 months)
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Virginia Kaklamani, MD
role: PRINCIPAL_INVESTIGATOR
References: