What side effects are associated with this type of intervention?

Common treatments for cancer, such as chemotherapy, often lead to side effects including peripheral neuropathy, which manifests as numbness, tingling, or pain in the limbs. The Paxman Limb Cryocompression System aims to prevent this by using cryocompression, continuous compression, and low cyclic compression. While specific side effects of these compression methods are not well-documented, general side effects of chemotherapy include fatigue, nausea, hair loss, and increased risk of infection. Cooling and compression therapies are generally well-tolerated but may cause discomfort or cold intolerance in some patients.

What prior FDA approvals exist?

The FDA has approved various treatments for cancer, including chemotherapeutic agents, targeted therapies, and immunotherapies. While specific FDA approvals for treatments using cooling and/or compression to prevent chemotherapy-induced peripheral neuropathy, like the Paxman Limb Cryocompression System, are not detailed, the agency has approved numerous supportive care treatments aimed at mitigating side effects of cancer therapies. These include drugs to manage pain, nausea, and other chemotherapy-induced conditions. The focus on supportive care highlights the importance of improving the quality of life for cancer patients undergoing treatment.

What other types of research exist?

Promising alternatives to the Paxman Limb Cryocompression System for preventing chemotherapy-induced peripheral neuropathy include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which uses electrical impulses to reduce nerve pain and improve nerve function. 2) Pharmacological agents such as duloxetine and gabapentin, which have shown efficacy in managing neuropathic pain. 3) Acupuncture, which has been studied for its potential to alleviate symptoms of neuropathy. 4) Cryotherapy using different devices or methods, such as ice packs or cooling gloves and socks, which may offer similar benefits to the Paxman system.

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Behavioural Intervention

Cooling/Compression Therapy for Chemotherapy-Induced Peripheral Neuropathy (ICE COMPRESS Trial)

Phase 3

Recruiting

Led By Katherine Pennington, MD

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, 24, and 52 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from cooling/compression of limbs during treatment sessions with the device. There's also a risk of adverse reactions related to temperature changes such as local skin issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, 24, and 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12, 24, and 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 24, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no)

Secondary study objectives

Dropouts

Mean sensory neuropathy scores

Rates of adverse events

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 (Continuous Compression)Experimental Treatment4 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 Treatment4 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 Control4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cryocompression, continuous compression, and low cyclic compression are treatments designed to prevent chemotherapy-induced peripheral neuropathy, a common side effect of taxane chemotherapy drugs. Cryocompression combines cooling and compression to reduce blood flow and nerve activity in the limbs, potentially minimizing nerve damage. Continuous compression applies steady pressure to the limbs, which may help in reducing swelling and improving blood circulation. Low cyclic compression alternates between applying and releasing pressure, which can enhance lymphatic drainage and reduce fluid buildup. These mechanisms are crucial for cancer patients as they help maintain limb function and quality of life during chemotherapy, reducing the risk of long-term nerve damage and associated complications.

Therapeutic effect of cryosurgery of murine osteosarcoma--influence on disease outcome and immune function.Ray Resection for Recurrent Invasive Squamous Cell Carcinoma: A Case Report.Locoregional management of in-transit metastasis in melanoma: an Ontario Health (Cancer Care Ontario) clinical practice guideline.