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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT04256512
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medical Device Usage and Evaluation — DEVICE
    Wear Elasto Gel Therapy Mittens and Foot Wraps
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Mar 10, 2020
Status verified
Jul 2025
Primary completion
Jan 18, 2023
Completion
Jan 18, 2023

Study Design

Enrollment
94 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.

Primary Outcome Measure

Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) [ Time Frame: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-

Find similar trials in Jacksonville, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic in Florida· Jacksonville, FL

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