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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Device: Medical Device Usage and Evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Device: Medical Device Usage and Evaluation; Wear Elasto Gel Therapy Mittens and Foot Wraps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral neuropathy (PN)	The overall estimate of PN in the group will be estimated with a simple percentage, and 95% confidence intervals will be calculated for that estimate. In additional other measures of symptoms or other parameters will be summarized in the group. Categorical parameters will be estimated using percentages, and continuous measures will be summarized using means, or medians. The decision about which measure to use for the continuous measures will depend on the distribution of the data of interest.	Up to 3 months post chemotherapy

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Pooja Advani, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 19-008929 (Other Identifier: Mayo Clinic in Florida); NCI-2021-02755 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes