Peripheral NeuropathiesNCT03329131

Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

A study testing Cryotherapy in people with Peripheral Neuropathies, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Neuropathies
What is being tested?: Cryotherapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 13 Nov 2017to 21 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed diagnosis of early stage breast cancer (stage I-III).
Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy.
Age > 18 years. There is no upper age limit for participation in this study.
Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation.
Prior chemotherapies are permitted, except with prior treatments with taxanes, vinca alcaloids, gemcitabine, eribulin, ixabepilone, platinum drugs)
All patients will have given signed, informed consent prior to registration
Patients must have a performance status of ECOG 0 or 1.

Who cannot join

Patients must not have received any prior taxane or platinum based chemotherapy.
Patients must not have a history of peripheral neuropathy (regardless of cause).
Patient must not have a history of Raynaud's disease.
Patients with partial or complete limb amputations.
Known hypersensitivity to cold
Patient cannot be on the following medications: GABA analogues (such as Neurontin, lyrica), tricyclic antidepressants (such as amitriptyline or nortriptyline)

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As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirements.
Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participant in the clinical trial
Must not be pregnant or breast feeding

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Health Cancer Center
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy

To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities

Read the detailed description

This is a therapeutic study investigating the use of cryotherapy in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) and associated nail toxicities. The therapeutic intervention will involve patients wearing an Elasto-Gel cold glove and sock on one hand and one foot (both on the right side or both on the left side). The patients will wear the glove and sock during each infusion of taxane chemotherapy.

Conditions: Peripheral Neuropathies
Being tested: Cryotherapy
Medical subject headings: Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CryotherapyDevice
Also called Cold therapy, Elasto gel™
An Elasto gel™ frozen (4°C) glove and sock

Study groups in NCT03329131
Study group	Role	What they receive
Cryotherapy	Experimental	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. Receives: Device: Cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevention of Peripheral Neuropathy During Taxane Chemotherapy
A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing "no pain" and 100mm representing "pain as bad as it could possibly be". The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity.
Measured: Change from baseline to 6 months post chemo (up to 14 months)
Evaluate Safety of Cryotherapy Use
Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes
Measured: Baseline to 6 months post Cryotherapy (up to 14 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201721 Sep 2020

First posted1 Nov 2017
Study start13 Nov 2017
Primary completion21 Sep 2020
Study completion21 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral NeuropathiesStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03329131
Sponsor's protocol ID: CTMS #17-0033
Other IDs: HSC20170535H
Status last verified: Sep 2024
First submitted: 27 Sep 2017
Last updated: 16 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
ClinicalTrials.gov ID: NCT03329131
Acronym / sponsor ID: CTMS #17-0033
Conditions: Peripheral Neuropathies
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Study start: 13 Nov 2017 (actual)
Primary completion: 21 Sep 2020 (actual)
Study completion: 21 Sep 2020 (actual)
First posted: 1 Nov 2017 (actual)
Results: Posted 16 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cryotherapy	Experimental	Device: CryotherapyEach 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Histologically confirmed diagnosis of early stage breast cancer (stage I-III).
Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy.
Age > 18 years. There is no upper age limit for participation in this study.
Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation.
Prior chemotherapies are permitted, except with prior treatments with taxanes, vinca alcaloids, gemcitabine, eribulin, ixabepilone, platinum drugs)

Key exclusion criteria (9 listed)

Patients must not have received any prior taxane or platinum based chemotherapy.
Patients must not have a history of peripheral neuropathy (regardless of cause).
Patient must not have a history of Raynaud's disease.
Patients with partial or complete limb amputations.
Known hypersensitivity to cold

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CryotherapyAlso: Cold therapy, Elasto gel™An Elasto gel™ frozen (4°C) glove and sock	Device	Cryotherapy

Primary outcome

Prevention of Peripheral Neuropathy During Taxane Chemotherapy
Time frame: Change from baseline to 6 months post chemo (up to 14 months)
A Visual analog scale (VAS) was used to assess change in pain after using a mustard oil challenge from pre- to post-infusion and the results reported as an average. The Visual Analogue Scale (VAS) is a tool that measures pain intensity by asking a patient to mark a point on a 100 mm line that represents their current pain level. The line has two endpoints, with 0mm representing "no pain" and 100mm representing "pain as bad as it could possibly be". The patient's score is determined by measuring the distance in millimeters from the left end of the line to the point they mark. A higher score indicates greater pain intensity.
Evaluate Safety of Cryotherapy Use
Time frame: Baseline to 6 months post Cryotherapy (up to 14 months)
Number of Adverse events Grade 3 or higher attributed to the use of Cryotherapy according to the National Cancer Institute - Common Terminology Criteria for Adverse Events NCI-CTCAE v 4.03 Assessment for peripheral neuropathy and nail changes

Results and safety

Results posted to the registry on 16 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cryotherapy	12	8

Primary outcome: Prevention of Peripheral Neuropathy During Taxane Chemotherapy

Time frame: Change from baseline to 6 months post chemo (up to 14 months). Mean (Full Range). Unit: score on a scale

Measure	Cryotherapy n = 7
Value	7.28 (0 to 29)

Population analysed: Only 7 of the subjects were evaluable, and not all data from all time points was available due to suspension of research activities during the pandemic

Primary outcome: Evaluate Safety of Cryotherapy Use

Time frame: Baseline to 6 months post Cryotherapy (up to 14 months). Number. Unit: Number of Adverse Events

Measure	Cryotherapy n = 8
Value	0

Population analysed: Only 8 of the subjects were evaluable for adverse events of Grade 3 or higher, and not all data from all time points was available due to suspension of research activities during the pandemic

Adverse events

Time frame: Adverse events were collected from baseline to 6 months post chemotherapy (variable depending on number of cycles of chemotherapy administered up to 14 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cryotherapy	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingPhase 1/2
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Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Virginia Kaklamani, MD principal investigator

The University of Texas Health Science Center at San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cryotherapy in people with Peripheral Neuropathies, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of Peripheral Neuropathy During Taxane Chemotherapy (time frame: Change from baseline to 6 months post chemo (up to 14 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03329131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.