Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT04256512
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2020-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: