Breast Cancer Clinical Trial

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

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.

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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.

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

80

Study ID:

NCT04256512

Recruitment Status:

Active, not recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Florida
Jacksonville Florida, 32224, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

80

Study ID:

NCT04256512

Recruitment Status:

Active, not recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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