Cooling/Compression Therapy for Chemotherapy-Induced Peripheral Neuropathy

(ICE COMPRESS Trial)

Recruiting at 28 trial locations

Overseen By Mariah Norman

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Southwest Oncology Group

Must be taking: Taxane chemotherapy

Must not be taking: Neurotoxic chemotherapy

Disqualifiers: Skin metastases, Peripheral neuropathy, Raynaud's, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

777 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if different cooling and compression therapies can prevent chemotherapy-induced peripheral neuropathy, a nerve disorder causing numbness or pain in the arms and legs. The study tests three methods: cryocompression therapy (cooling with pressure), continuous compression therapy (steady pressure), and low cyclic compression (intermittent pressure). Each method uses a special device on the arms and legs to prevent nerve problems caused by certain chemotherapy drugs. Individuals diagnosed with a solid tumor and about to start specific chemotherapy treatments might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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

What prior data suggests that the Paxman Limb Cryocompression System is safe for preventing chemotherapy-induced peripheral neuropathy?

Research shows that both cryocompression therapy and pneumatic compression therapy are generally safe for people receiving chemotherapy.

Cryocompression involves cooling and squeezing the limbs. Studies have found it to be safe and well-tolerated, helping to reduce the risk of nerve damage, which can cause numbness or pain, from chemotherapy drugs like paclitaxel and docetaxel.

Pneumatic compression therapy uses gentle pressure to squeeze the arms and legs. Research involving 442 patients showed it is safe and effectively reduces the chance of developing nerve damage from chemotherapy.

Both therapies aim to prevent nerve damage without causing major side effects, making them promising options for those undergoing chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for chemotherapy-induced peripheral neuropathy because they offer innovative approaches to managing symptoms. Unlike standard treatments that often rely on medications to alleviate nerve pain, these therapies use physical methods like cooling and compression to target discomfort. Cryocompression therapy combines cooling with variable pressure to the limbs, potentially reducing nerve damage during chemotherapy. Continuous compression applies steady pressure, which might help maintain blood flow and prevent nerve injury. Low cyclic compression uses gentle, pulsing pressure, aiming to soothe nerves and improve patient comfort. These methods offer non-drug alternatives that could minimize side effects and enhance quality of life for patients undergoing chemotherapy.

What evidence suggests that this trial's treatments could be effective for preventing chemotherapy-induced peripheral neuropathy?

Research has shown that cryocompression therapy, a treatment in this trial, uses cold and pressure to safely and effectively reduce nerve damage from chemotherapy. Studies have found that cooling the arms and legs decreases the risk of nerve problems. Similarly, pneumatic compression therapy, another option in this trial, applies pressure to reduce nerve damage and has cut the risk of nerve issues by half in some studies. As a result, fewer people experience numbness, tingling, or pain in their arms and legs. Both treatments show promise in preventing nerve problems during chemotherapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Melissa K Accordino

Principal Investigator

SWOG - Columbia University

Katherine Pennington, MD

Principal Investigator

NRG - University of Washington

Are You a Good Fit for This Trial?

This trial is for adults with solid tumor cancers starting specific chemotherapy within 3 days. They must be able to complete questionnaires in English or Spanish, consent to the study, and agree to provide specimen samples. Excluded are those with skin/limb metastases, prior neurotoxic chemo, open limb wounds, existing neuropathy, or certain cold-related disorders.

Inclusion Criteria

I agree to fill out health questionnaires as scheduled and before starting the trial.

Participants must be offered the opportunity to participate in specimen banking

Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

I do not have any open skin wounds or ulcers on my limbs.

I have never had cancer spread to my skin or limbs.

I have never received chemotherapy that could harm my nerves.

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 undergo cryocompression, continuous compression, or low cyclic compression during taxane chemotherapy infusions

12 weeks

Weekly visits during chemotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

Visits at 24 and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cryocompression Therapy
• Pneumatic Compression Therapy

Trial Overview The trial compares three methods using the Paxman Limb Cryocompression System: cryocompression (cooling), continuous compression, and low cyclic compression on arms and legs. It aims to prevent numbness or pain caused by taxane chemotherapy drugs like paclitaxel or docetaxel.

How Is the Trial Designed?

Group I: Arm 2 (Continuous Compression) Experimental Treatment 4 Interventions

Patients undergo continuous compression (moderate, steady pressure to the arms and legs) for 30-minutes pre-taxane chemotherapy infusion, during taxane chemotherapy infusion, and for 30 minutes after completion of each taxane infusion. Patients may also undergo collection of blood, serum and plasma samples during screening and on study.

Group II: Arm 1 (Cryocompression) Experimental Treatment 4 Interventions

Patients undergo cryocompression (cooling plus moderate and low pressure to the arms and legs) for 30-minutes pre-taxane chemotherapy infusion, during taxane chemotherapy infusion, and for 30 minutes after completion of each taxane infusion. Patients may also undergo collection of blood, serum and plasma samples during screening and on study.

Group III: Arm 3 (Low Cyclic Compression) Active Control 4 Interventions

Patients undergo low cyclic compression (low pressure that comes and goes to the arms and legs) for 30-minutes pre-taxane chemotherapy infusion, during taxane chemotherapy infusion, and for 30 minutes after completion of each taxane infusion. Patients may also undergo collection of blood, serum and plasma samples during screening and on study.

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 43 breast cancer patients receiving nab-PTX, both cryotherapy using a frozen glove and compression therapy using a surgical glove were found to be equally effective in preventing peripheral neuropathy, with no significant differences in neuropathy incidence between the two methods.

The frozen glove group had significantly lower fingertip temperatures compared to the surgical glove group after treatment, indicating that cryotherapy effectively reduced temperature, but this did not translate into a difference in neuropathy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of cryotherapy and compression therapy for preventing nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: A prospective self-controlled trial. Kanbayashi, Y., Sakaguchi, K., Ishikawa, T., et al.[2020]

Cryocompression therapy significantly reduced the odds of developing severe chemotherapy-induced peripheral sensory neuropathy by 46% in gynecologic cancer patients undergoing neurotoxic chemotherapy, based on a study of 69 eligible participants.

The therapy was well-accepted by patients, with over 85% finding it acceptable and tolerable, indicating its potential as a supportive treatment during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial. Anastasio, MK., Unnithan, S., Scott, A., et al.[2023]

In a study involving 58 healthy subjects, both continuous-flow cooling and cryocompression were found to be safe and tolerable methods for inducing limb hypothermia, with no serious adverse events reported except for minor skin redness.

Cryocompression achieved lower skin temperatures compared to continuous-flow cooling and may be more effective in preventing chemotherapy-induced peripheral neuropathy (CIPN), with clinical trials planned to test this in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limb Hypothermia for the Prevention of Chemotherapy-Induced Peripheral Neuropathy - Modality for Optimal Cooling. Bandla, A., Santhanakrishnan, P., Magarajah, G., et al.[2020]

In a study of 36 breast cancer patients undergoing weekly paclitaxel treatment, cryotherapy using frozen gloves and socks significantly reduced the incidence of chemotherapy-induced peripheral neuropathy (CIPN) symptoms, with tactile sensitivity issues dropping from 80.6% to 27.8% in hands and from 63.9% to 25.0% in feet.

The results showed that cryotherapy not only lowered the objective signs of CIPN but also improved subjective symptoms and dexterity, indicating it is an effective preventive measure against this debilitating side effect of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. Hanai, A., Ishiguro, H., Sozu, T., et al.[2019]

In a proof-of-concept study involving 13 cancer patients undergoing taxane chemotherapy, cryocompression was well tolerated and achieved a significant mean skin temperature reduction of 3.8 °C, which was greater than that achieved with continuous-flow cooling.

Patients receiving cryocompression did not experience severe neuropathy, and nerve conduction studies indicated better preservation of motor nerve function compared to controls, suggesting that cryocompression may effectively reduce neurotoxicity associated with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. Bandla, A., Tan, S., Kumarakulasinghe, NB., et al.[2021]

In a randomized trial involving 63 patients undergoing taxane chemotherapy, compression therapy was found to be the most effective method for preventing chemotherapy-induced peripheral neuropathy (CIPN), with a success rate of 64.7% compared to 41.1% for both cryotherapy and placebo.

Adherence to the interventions was notably lower for cryotherapy (35.0%) compared to compression (72.7%) and placebo (76.2%), suggesting that compression therapy is not only more effective but also better tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. Accordino, MK., Lee, S., Leu, CS., et al.[2023]

Citations

1. 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 ...

2. 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.

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. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624000948

Cropsi study: Efficacy and safety of cryotherapy and ... Our study suggests that cryotherapy as well as cryocompression is a safe and effective way to cool patients' extremities to lower the prevalence of CIPN.

5. paxmanscalpcooling.com paxmanscalpcooling.com/cipn-clinical-trial-with-national-university-hospital-singapore/

CIPN Clinical Trial with National University Hospital ... The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy (CIPN)

6. 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 ... The study concludes that the use of limb cryocompression: is safe and well-tolerated in patients receiving taxane-based chemotherapy; can be ...