NCT04256512

Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients

Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To investigate the efficacy and tolerability of cryotherapy (Elasto Gel frozen mittens and foot wraps) and to evaluate whether they can prevent or ameliorate taxane-induced sensory peripheral neuropathy. OUTLINE: Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
DEVICE	Medical Device Usage and Evaluation	Wear Elasto Gel Therapy Mittens and Foot Wraps
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-03-10
• Primary completion: 2023-01-18
• Completion: 2023-01-18
• First posted: 2020-02-05
• Last updated: 2025-07-28
• Results posted: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study