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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2023-01-18

Brief Summary

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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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Detailed Description

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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

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prevention (Elasto Gel Therapy Mittens and Foot Wraps)

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.

Group Type EXPERIMENTAL

Medical Device Usage and Evaluation

Intervention Type DEVICE

Wear Elasto Gel Therapy Mittens and Foot Wraps

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Medical Device Usage and Evaluation

Wear Elasto Gel Therapy Mittens and Foot Wraps

Intervention Type DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No