777 Participants Needed

Cooling/Compression Therapy for Chemotherapy-Induced Peripheral Neuropathy

(ICE COMPRESS Trial)

Recruiting at 28 trial locations
JT
MN
Overseen ByMariah Norman
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Southwest Oncology Group
Must be taking: Taxane chemotherapy
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

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.12456

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.12456

Who Is on the Research Team?

MK

Melissa K Accordino

Principal Investigator

SWOG - Columbia University

KP

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
See 4 more

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.
See 2 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 (Continuous Compression)Experimental Treatment4 Interventions
Group II: Arm 1 (Cryocompression)Experimental Treatment4 Interventions
Group III: Arm 3 (Low Cyclic Compression)Active Control4 Interventions

Find a Clinic Near You

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

Citations

Limb Hypothermia for the Prevention of Chemotherapy-Induced Peripheral Neuropathy - Modality for Optimal Cooling. [2020]
Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. [2021]
Cryocompression to Reduce Peripheral Neuropathy in Gynecologic Cancer: A Randomized Controlled Trial. [2023]
Comparison of the efficacy of cryotherapy and compression therapy for preventing nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: A prospective self-controlled trial. [2020]
Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. [2023]
Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. [2019]
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