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

Breast Carcinoma Clinical Trial

Official title:

Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256512
• Other study ID #: 19-008929
• Secondary ID: NCI-2021-0275519
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: January 18, 2023

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Device:
• Medical Device Usage and Evaluation
Wear Elasto Gel Therapy Mittens and Foot Wraps

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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