Clinical Trials

Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy (CTMS# 17-0033)

Breast

NCT03329131

Virginia Kaklamani, MD

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About This Study

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

Note: This is only a partial list of 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