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Cryotherapy for Peripheral Neuropathy

N/A
Waitlist Available
Led By Virginia Kaklamani, MD
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
Must not have
Patient must not have a history of Raynaud's disease
Patient cannot be on the following medications: GABA analogues (such as Neurontin, lyrica), tricyclic antidepressants (such as amitriptyline or nortriptyline)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months post cryotherapy (up to 14 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if wearing cold gloves and socks during treatment can help prevent nerve damage in patients' hands and feet. Using frozen gloves has been shown to reduce nerve-related issues in breast cancer patients.

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.
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.
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).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had Raynaud's disease.
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I am not taking GABA analogues or tricyclic antidepressants.
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I have never had peripheral neuropathy.
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I have never been treated with taxane or platinum-based chemotherapy.
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I have had a partial or complete limb amputation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months post cryotherapy (up to 14 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months post cryotherapy (up to 14 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate Safety of Cryotherapy Use
Prevention of Peripheral Neuropathy During Taxane Chemotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2240

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral neuropathy treatments aim to alleviate symptoms and address underlying causes. Common treatments include medications like gabapentin and tricyclic antidepressants, which reduce pain by modulating nerve signals. Cryotherapy, such as cold gloves and socks, reduces blood flow to extremities, potentially decreasing inflammation and nerve damage. This matters for patients as it can significantly reduce the severity of neuropathy symptoms, improving quality of life and functional ability.
Cryotherapy for Prevention of Taxane-Induced Peripheral Neuropathy: A Meta-Analysis.Neurovascular hand symptoms in relation to cold exposure in northern Sweden: a population-based study.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,907 Total Patients Enrolled
Virginia Kaklamani, MDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
4 Previous Clinical Trials
310 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
~1 spots leftby Dec 2025