Cryocompression for Peripheral Neuropathy

Overseen By Theresa Jabaley Leonarczyk, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Taxane-based chemotherapy

Disqualifiers: Pre-existing neuropathy, Raynaud's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new cooling and pressure device, the Paxman Limb Cryocompression System, can reduce nerve damage symptoms in patients undergoing taxane-based chemotherapy. This nerve damage, known as peripheral neuropathy, can cause numbness, pain, or difficulty moving limbs. The trial compares the use of the device plus standard chemotherapy to chemotherapy alone. Individuals beginning their first round of certain chemotherapy treatments for gynecologic or breast cancer, who can complete questionnaires in English or Spanish, might be suitable candidates.

As an unphased trial, this study allows patients to contribute to innovative research that could enhance quality of life during chemotherapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Paxman Limb Cryocompression System is safe for reducing peripheral neuropathy?

Research shows that the Paxman Limb Cryocompression System is safe and well-tolerated. Studies indicate it is safe for patients receiving taxane-based chemotherapy, which can cause peripheral neuropathy. This condition affects nerves in the arms and legs, leading to numbness or pain.

The cryocompression system uses cooling and pressure to help reduce these side effects. Previous research has found that this system is not only safe but also practical to use. Participants in studies have generally tolerated it well, with no major safety concerns reported.

These findings suggest that joining a trial using this system involves minimal risks. The system has undergone sufficient testing to demonstrate it is unlikely to cause serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Paxman Limb Cryocompression System because it offers a unique approach to managing peripheral neuropathy, especially for patients undergoing taxane-based chemotherapy. Unlike traditional options that focus on medication for symptom relief, this system uses cryocompression—a technique involving cold and pressure—to potentially prevent nerve damage from chemotherapy. This method could not only reduce the severity of neuropathy symptoms but also improve patients' overall quality of life by allowing them to maintain their chemotherapy dosing without interruption due to side effects.

What evidence suggests that the Paxman Limb Cryocompression System is effective for reducing peripheral neuropathy?

Research has shown that the Paxman Limb Cryocompression System, which participants in this trial may receive, might help reduce nerve damage caused by chemotherapy, potentially preventing numbness or pain. Studies have found that cold therapy can help prevent this type of nerve damage. In one study, 84% of patients completed their treatments using cryocompression, indicating it is generally well-tolerated. Early results also suggest that applying cold and pressure to the arms and legs during chemotherapy can reduce nerve issues. This therapy appears promising for individuals receiving taxane-based chemotherapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Leonarczyk

Principal Investigator

Dana-Farber Cancer Institute

Theresa Jabaley Leonarczyk, PhD, RN

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with gynecologic or breast malignancies starting their first cycle of specific chemotherapy at DFCI's main campus. They must be able to complete questionnaires in English or Spanish. It excludes those with pre-existing neuropathy, prior neurotoxic chemotherapy, certain blood and circulation disorders, lymphedema in the treatment limb, or open skin wounds on that limb.

Inclusion Criteria

Receiving treatment on the main campus of DFCI

I have been diagnosed with cancer in my reproductive organs or breasts.

I am starting my first round of a specific chemotherapy treatment.

Exclusion Criteria

Pre-existing neuropathy

I have been treated with chemotherapy that can affect the nerves.

I have a history of conditions like Raynaud's or sickle cell disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive standard of care taxane-based chemotherapy with or without cryocompression

Up to 12 weeks

Multiple visits (in-person) for chemotherapy infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of CIPN symptoms

1-4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Paxman Limb Cryocompression System

Trial Overview The study tests the Paxman Limb Cryocompression System (PLCS), a device providing cooling therapy and pressure to limbs. It aims to see if this can reduce nerve damage symptoms like numbness and pain caused by taxane-based chemotherapy treatments.

How Is the Trial Designed?

Group I: Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy Experimental Treatment 1 Intervention

Participants will be randomized and stratified by chemotherapy regimen and will complete: * Baseline visit with questionnaires * Standard of care chemotherapy visits with cryocompression * End of treatment visit

Group II: Arm B: Standard of Care Taxane-based Chemotherapy Active Control 1 Intervention

Participants will be randomized and stratified by chemotherapy regimen and will complete: * Baseline visit with questionnaires * Standard of care chemotherapy visits * End of treatment visit

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Theresa Jabaley, PhD

Lead Sponsor

Paxman Coolers Limited

Collaborator

Trials

1

Recruited

120+

Citations

1. paxmanscalpcooling.com paxmanscalpcooling.com/paxman-limb-cryocompression-system-swog-clinica-trial/

Paxman Limb Cryocompression System to be used in ... The study will assess the safety, tolerability, and satisfaction with cryocompression therapy and compression therapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05095051

A Novel Limb Cryocompression System for Prevention of ... The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39937296/

Safety and feasibility of concomitant scalp cooling and limb ... Limb cryotherapy has shown promise in preventing chemotherapy-induced peripheral neuropathy (CIPN). The safe application of concomitant scalp ...

4. paxmanscalpcooling.com paxmanscalpcooling.com/mascc-afsos-isoo-2024-annual-meeting-features-presentation-of-important-preliminary-data-in-cryotherapy-side-effect-management-for-safety-efficacy-of-paxman-limb-cryocompression-device/

MASCC/AFSOS/ISOO 2024 Annual Meeting Features ... Dr Wong updated the audience of the latest multi-centre trial results from Singapore, utilising the novel Paxman Limb Cryocompression Device, ...

5. storage.mfn.se storage.mfn.se/7eb31eb6-0091-4939-aa28-30abc0577c98/paxman-announces-progress-of-its-clinical-trial-for-chemotherapy-induced-peripheral-neuropathy-with-latest-data-presented-at-eons18-conference-part-of-esmo-r-congress-2025.pdf

paxman-announces-progress-of-its-clinical-trial-for- ... In this latest data release 94 patients were involved in the study and 84% (79/94) of patients completed all planned treatments with cryo- ...

6. link.springer.com link.springer.com/article/10.1007/s00520-024-08982-6

Safety and feasibility of concomitant scalp cooling and ... Concomitant scalp cooling and limb cryocompression is safe, feasible, and relatively well tolerated by healthy volunteers and cancer patients as ...