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Cryotherapy for Peripheral Neuropathy

N/A

Waitlist Available

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy

Prior chemotherapies are permitted, except with prior treatments with taxanes, vinca alkaloids, gemcitabine, eribulin, ixabepilone, platinum drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 6 months post chemo

Awards & highlights

Study Summary

This trial is testing whether cold gloves and socks can help reduce chemotherapy-induced neuropathy in the extremities.

Who is the study for?

This trial is for adults over 18 with early stage breast cancer (stage I-III) who are about to start taxane-based chemotherapy. They can have had other treatments but not with certain drugs like taxanes or platinum. Participants must be in good physical condition and not have a history of neuropathy, Raynaud's disease, limb amputations, cold hypersensitivity, severe medical conditions that affect study compliance, or be pregnant/breastfeeding.Check my eligibility

What is being tested?

The trial is testing if wearing cold gloves and socks during chemotherapy can reduce the rate and severity of nerve damage in hands and feet compared to limbs without protection. This method aims to prevent peripheral neuropathy caused by chemo.See study design

What are the potential side effects?

While the side effects aren't detailed here, cryotherapy could potentially cause discomfort due to cold exposure such as temporary numbness or tingling in treated extremities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for chemotherapy that includes taxane before or after surgery.

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I have had chemotherapy, but not with drugs like taxanes or platinum.

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I can perform daily activities without significant limitations.

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My breast cancer is confirmed and in an early stage (I-III).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 6 months post chemo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 6 months post chemo

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months post chemo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevention of peripheral neuropathy during taxane chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: CryotherapyExperimental Treatment1 Intervention

Each patient will receive cryotherapy administered during each neurotoxic chemotherapy agent infused treatments by Elasto gel™ Hypothermia gloves and socks. Patients will wear the glove and sock for 15 minutes prior to treatment start and 15 minutes following treatment completion, for a total of 30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cryotherapy

2011

Completed Phase 4

~2280

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,399 Total Patients Enrolled

Media Library

Cryotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03329131 — N/A

Peripheral Neuropathy Research Study Groups: Cryotherapy

Peripheral Neuropathy Clinical Trial 2023: Cryotherapy Highlights & Side Effects. Trial Name: NCT03329131 — N/A

Cryotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03329131 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this medical experiment at present?

"Unfortunately, according to the clinicaltrials.gov website, this trial is not presently enrolling participants; however, it was initially posted on November 13th 2017 and last updated January 20th 2022. Fortunately for those interested in participation, there are 161 other active trials at present recruiting patients."

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