Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Completed · Not applicable
Conditions studied: Peripheral Neuropathies
In brief
To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities
Key facts
- Study ID
- NCT03329131
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 12
- Starts
- 2017-11-13
- Expected to finish
- 2020-09-21
- Last updated by the study team
- 2024-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- UT Health Cancer Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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