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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
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 moreAwards & 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
~2020
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.
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.
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,410 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,825 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,261 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any open skin wounds or ulcers on my limbs.I agree to fill out health questionnaires as scheduled and before starting the trial.I have never had cancer spread to my skin or limbs.I have never received chemotherapy that could harm my nerves.I do not have nerve damage in my hands or feet.I am 18 years old or older.I have never had Raynaud's or related cold-triggered conditions.I can complete health questionnaires in English or Spanish.I have been diagnosed with a solid tumor cancer.I am starting chemo as per the study plan within 3 days after being chosen for the trial.If I can't make decisions, my legal representative can consent for me.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3 (Low Cyclic Compression)
- Group 2: Arm 2 (Continuous Compression)
- Group 3: Arm 1 (Cryocompression)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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