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Behavioural Intervention
Cooling/Compression Therapy for Chemotherapy-Induced Peripheral Neuropathy (ICE COMPRESS Trial)
Phase 3
Recruiting
Led By Melissa K Accordino
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
ICE COMPRESS Trial Summary
This trial will test 3 approaches to preventing nerve disorder caused by taxane chemotherapy. A device of cooling/compressing wraps will be used on arms/legs. Results may help determine if any of the approaches can prevent peripheral neuropathy.
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.Check my eligibility
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.See study design
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.
ICE COMPRESS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no)
Secondary outcome measures
Dropouts
Mean sensory neuropathy scores
Rates of adverse events
+1 moreICE COMPRESS 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 2
~1730
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,034 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,393 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,923,557 Total Patients Enrolled
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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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards are associated with Cryocompression treatment?
"Our team at Power has determined that cryocompression, or Arm 1 of the trial, is comparatively safe with a score of 3. This rating was made based on its Phase 3 status; substantiating evidence already exists concerning both safety and efficacy."
Answered by AI
Are there vacancies available in this trial that are open to prospective participants?
"Affirmative. As evidenced by information published on clinicaltrials.gov, this medical experiment is recruiting, and was first mentioned on March 16th 2023. The study has since been updated; it aims to enrol 777 patients at a single site."
Answered by AI
What is the participant enrollment for this trial?
"Correct. Clinicaltrials.gov reveals that this trial, which was first made available to prospective participants on March 16th 2023, is presently recruiting. A total of 777 patients need to be enrolled from 1 location for the study's completion."
Answered by AI
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