What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Peripheral neuropathy treatments can vary widely, but common approaches include medications, physical therapy, and lifestyle modifications. For treatments similar to cold gloves and socks, which aim to reduce blood flow to extremities, side effects are generally minimal but can include discomfort from the cold, potential frostbite if not monitored properly, and temporary numbness. Other common treatments like gabapentin and tricyclic antidepressants may cause dizziness, drowsiness, and dry mouth. Topical treatments with amitriptyline and ketamine can cause skin irritation. It's important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for peripheral neuropathy primarily include medications such as gabapentin, pregabalin, and duloxetine, which are used to manage neuropathic pain. While these drugs do not specifically reduce blood flow to extremities, they help alleviate symptoms. The use of cold gloves and socks, which aims to reduce blood flow to mitigate chemotherapy-induced neuropathy, is a novel approach and not yet a standard FDA-approved treatment. Other non-pharmacological interventions, such as physical therapy and lifestyle modifications, are also commonly recommended.

What other types of research exist?

Promising novel alternatives to cold gloves and socks for peripheral neuropathy patients include: 1) At-home infrared temperature monitoring, which has shown effectiveness in preventing diabetes-related lower-extremity ulceration and amputation. 2) Advanced pneumatic compression devices, which have demonstrated clinical and quality-of-life benefits in patients with lymphedema and could potentially be adapted for neuropathy management. 3) Lower extremity resistance training, which improves vasodilation and clinical parameters without adverse effects, offering a non-invasive exercise-based approach.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months post cryotherapy (up to 14 months)

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

0 / 9Eligibility criteria met

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.