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

Mayo Clinic

Status: Completed

Conditions: Breast Carcinoma

Treatments: Device: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04256512

19-008929

NCI-2021-02755 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

Prevention (Elasto Gel Therapy Mittens and Foot Wraps)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Device: Medical Device Usage and Evaluation