N/A
N=12
Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
Peripheral Neuropathies
Bottom Line
View on ClinicalTrials.gov: NCT03329131 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Prevention of Peripheral Neuropathy During Taxane Chemotherapy — 7.28 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryotherapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevention of Peripheral Neuropathy During Taxane Chemotherapy |
7.28 | — |
| PRIMARY Evaluate Safety of Cryotherapy Use |
— | — |
Summary
To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities
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
Data sourced from ClinicalTrials.gov (NCT03329131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.