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

Trial Summary

What is the purpose of this trial?

This trial tests three methods to prevent nerve damage in patients receiving taxane chemotherapy. The methods involve using special wraps that either cool the limbs, apply steady pressure, or apply gentle pressure that comes and goes. These approaches aim to protect nerves from the harmful effects of chemotherapy drugs. Cooling the limbs has been well-tolerated and is a reasonable option to prevent nerve damage in patients receiving taxane-based treatments.

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 data supports the effectiveness of the treatment Cooling/Compression Therapy for Chemotherapy-Induced Peripheral Neuropathy?

Research suggests that cryocompression therapy, which combines cooling and compression, may help prevent chemotherapy-induced peripheral neuropathy (nerve damage from cancer treatment). Studies have shown that cryocompression can achieve lower skin temperatures safely and may be more effective than other cooling methods like frozen gloves. ^{1 2 3 4 5}

Is cooling/compression therapy safe for humans?

Research shows that cooling/compression therapy, including cryocompression, is generally safe for humans. In studies with healthy subjects, no serious side effects were observed, only mild skin redness that went away quickly. ^{1 2 3 4 6}

How is cryocompression therapy different from other treatments for chemotherapy-induced peripheral neuropathy?

Cryocompression therapy combines cooling and compression to prevent chemotherapy-induced peripheral neuropathy, offering a unique approach that may improve efficacy and safety compared to traditional methods like frozen gloves, which can cause cold intolerance and frostbite. This treatment provides thermoregulated cooling with dynamic pressure, potentially allowing for lower temperatures with better tolerance and effectiveness. ^{1 2 3 4 5}

Research Team

Melissa K Accordino

Principal Investigator

SWOG - Columbia University

Katherine Pennington, MD

Principal Investigator

NRG - University of Washington

Eligibility Criteria

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.

I am 18 years old or older.

Participants must be offered the opportunity to participate in specimen banking

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Limb Hypothermia for the Prevention of Chemotherapy-Induced Peripheral Neuropathy - Modality for Optimal Cooling. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial. [2023]

4. Netherlands 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. [2020]

5. Netherlands 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. [2019]