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

NCT04256512 | Completed Results FDA Device

• 2 other identifiers: 19-008929NCI-2021-02755
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN)

  Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).

  During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up

Study Arms (1)

Prevention (Elasto Gel Therapy Mittens and Foot Wraps)

EXPERIMENTAL

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.

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

Interventions

Medical Device Usage and Evaluation DEVICE

Wear Elasto Gel Therapy Mittens and Foot Wraps

Prevention (Elasto Gel Therapy Mittens and Foot Wraps)

Questionnaire Administration OTHER

Ancillary studies

Prevention (Elasto Gel Therapy Mittens and Foot Wraps)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Pooja P. Advani, MBBS
• Organization: Mayo Clinic

Advani.Pooja@mayo.edu

904-953-7291

Study Officials

• Pooja Advani, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: March 10, 2020
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Locations

US (1)