N/A
N=94
Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04256512 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) — 41; 30; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medical Device Usage and Evaluation (Device); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) |
41; 30; 25 | — |
Summary
This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.
Eligibility Criteria
Inclusion Criteria
- Patients >= 18 years of age with a diagnosis of breast cancer
- Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks)
- Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ability to complete questionnaires by themselves or with assistance
- Ability to give signed informed consent
Exclusion Criteria
- History of prior sensory/motor peripheral neuropathy from any cause
- History of prior Raynaud's phenomenon
- History of cryoglobulinemia
- Active peripheral vascular disease
- Cold intolerance
- Prior exposure to neurotoxic chemotherapy in the last 10 years
- Hand-foot syndrome
- Tumor metastasis in bone, soft tissue, or skin of the hands or feet
- Absence of one or more fingers or toes
- Prior exposure to taxane chemotherapy
Data sourced from ClinicalTrials.gov (NCT04256512). 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.