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Malignant Solid NeoplasmPhase 3ICE COMPRESSNCT05642611

Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy

A Phase 3 study testing Biospecimen Collection, Cryocompression Therapy and Pneumatic Compression Therapy in people with Malignant Solid Neoplasm, run by SWOG Cancer Research Network at 36 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Neoplasm
What is being tested?
Biospecimen Collection, Cryocompression Therapy and Pneumatic Compression Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
777 participants
Where
36 sitesUnited States
Study dates
6 Jun 2023to 30 Aug 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a diagnosis of a solid tumor malignancy.
  • Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid tumor malignancy within 3 calendar days after randomization.
  • Weekly paclitaxel x 12 consecutive weeks
  • Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
  • Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
  • Docetaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery NOTE: For any of the protocol-specified chemotherapy regimens, concurrent targeted therapy with biologic therapy is allowed. Pembrolizumab (or other immune checkpoint inhibitors), trastuzumab and/or pertuzumab, or bevacizumab are allowed.
Show all 12Show fewer
  • Participant must be >= 18 years old.
  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
  • Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
  • Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
  • 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.
  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations.

Who cannot join

  • Participants must not have a history of skin or limb metastases.
  • Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
  • Participants must not have pre-existing clinical peripheral neuropathy from any cause.
  • Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.
  • Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Justine Trevino contact

210-614-8808

jtrevino@swog.org

Mariah Norman contact

210-614-8808

mnorman@swog.org

36 sites in 1 country

United States36 sites, 33 recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Bernard Tawfik

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Demetria Smith-Graziani

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, gingerreeves@uabmc.edu

    Nusrat Jahan

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Dawn M. Severson

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Dawn M. Severson

    Recruiting

  • STCC at DHR Health Institute for Research and Development

    Edinburg, Texas, 78539

    Site Public Contact, 956-362-2390, dhrresearch@dhr-rgv.com

    Jose Cruz

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Maryam B. Lustberg

    Recruiting

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

    Site Public Contact, 843-777-0770, dorie.sturgill@mcleodhealth.org

    Rajesh Bajaj

    Recruiting

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Isaac Alwine

    Recruiting

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

    Site Public Contact, 704-834-2810, tammy.cozad@caromonthealth.org

    Bolanle Gbadamosi

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Isaac Alwine

    Recruiting

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

    Site Public Contact, 828-696-4716, pardeecancerresearch@unchealth.unc.edu

    John K. Hill

    Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    Christa Braun-Inglis

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Julie R. Nangia

    Recruiting

  • Regional Cancer Center at Johnson City Medical Center

    Johnson City, Tennessee, 37604

    Site Public Contact, 423-431-5654, charles.mays@balladhealth.org

    Asheesh Shipstone

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Lauren Nye

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Elaine P. Kuhn

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Site Public Contact, 859-260-6425

    Arvinda Padmanabhan

    Recruiting

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

    Suspended

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    William J. Irvin

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Maryam B. Lustberg

    Recruiting

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

    Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu

    Melissa K. Accordino

    Recruiting

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Lauren Nye

    Recruiting

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

    Site Public Contact, 201-634-5792, clinicaltrialsresearch@valleyhealth.com

    Eleonora Teplinsky

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Site Public Contact, 401-444-1488

    Stephanie L. Graff

    Recruiting

  • Valley Health System Ridgewood Campus

    Ridgewood, New Jersey, 07450

    Site Public Contact, 201-634-5792, clinicaltrialsresearch@valleyhealth.com

    Eleonora Teplinsky

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Suspended

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Site Public Contact, 800-804-8824

    Renata Urban

    Recruiting

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Isaac Alwine

    Recruiting

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Active, not recruiting

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Maryam B. Lustberg

    Recruiting

  • SMC Center for Hematology Oncology Union

    Union, South Carolina, 29379

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Isaac Alwine

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Lauren Nye

    Recruiting

Other trials in United States

About this study

Official title: Ice Compress: Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy

This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs. The 3 study approaches will use a device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress the arms and legs. This study may help researchers determine if any of the study approaches are able to prevent taxane chemotherapy from causing peripheral neuropathy.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the proportion of participants who develop clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) at 12 weeks, in participants treated with taxane-based chemotherapy randomized to cryocompression therapy versus continuous compression therapy versus low cyclic compression therapy.

SECONDARY OBJECTIVES:

  1. To compare trajectories over time (6, 12, 24, and 52 weeks) by intervention study arm in clinically meaningful CIPN.

II. To compare mean European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC-CIPN-20) sensory neuropathy subscale scores at 12 weeks by intervention study arm.

III. To compare differences by intervention study arm at 12 weeks in changes from baseline in objective sensory and motor function tests (Neuropen, tuning fork, Timed Get Up and Go test).

IV. To compare the proportion of participants who develop clinically meaningful CIPN at 12 weeks in a sensitivity analysis with dropouts treated as failures.

  1. To compare rates of adverse events related to study device at 12 weeks (including cold intolerance, skin changes, other adverse events [AEs] as assessed by Common Terminology Criteria for Adverse Events [CTCAE]) between the three interventions.

ADDITIONAL OBJECTIVES:

  1. To compare the proportion of participants who develop clinically meaningful CIPN separately at weeks 6, 24, and 52.

II. To compare the proportion of participants who develop clinically meaningful CIPN at week 12 with additional covariate adjustment for age and body mass index (BMI).

III. To compare differences by intervention study arm at 12 weeks in mean EORTC CIPN-20 motor subscale score and autonomic subscale score, and in mean individual Patient-Reported Outcomes Measurement Information System (PROMIS)-29 domain (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, Pain Interference, and Pain Intensity) scores.

IV. To compare trajectories over time (6, 12, 24, and 52 weeks) by intervention study arm in mean EORTC CIPN-20 sensory neuropathy subscale score, motor subscale score, and autonomic subscale score; and in mean PROMIS-29 individual domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, Pain Interference, and Pain Intensity) scores; and in changes in objective sensory and motor function tests (Neuropen, tuning fork, Timed Get Up and Go test).

  1. To evaluate the differences by intervention study arm in proportion of participants who develop clinically meaningful CIPN at 12 weeks by chemotherapy regimen.

VI. To assess the effect of the intervention in reducing CIPN occurring in the upper extremities and, separately, in the lower extremities.

VII. To explore the relationship between duration of intervention received at the prescribed level and outcome, analogous to a dose-delivered analysis in a treatment trial.

VIII. To compare rates by study arm of CTCAE Grade 2 or higher sensory and motor neuropathy at 12 weeks.

IX. To evaluate tolerability of cryocompression compared to continuous compression therapy and low cyclic compression therapy, as assessed by rate of temperature and/or pressure adjustments, interruptions, and early discontinuation of the device.

  1. To determine participant satisfaction of cryocompression compared to continuous compression therapy and low cyclic compression therapy, assessed by patient questionnaire.

XI. To compare taxane dose-reductions, treatment delays/discontinuation due to CIPN, and relative taxane dose intensity and total taxane dose received, between intervention study arms.

XII. To evaluate differences of intervention effect by sex, race, and ethnicity.

XIII. To confirm pretreatment biomarkers of CIPN risk (vitamin D) and on-treatment biomarker changes indicative of CIPN severity (Neurofilament light chain, NFL) as well as additional biomarkers of interest generated in S1714 for validation.

BANKING OBJECTIVE:

  1. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM 1: 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.

ARM 2: 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.

ARM 3: 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.

Being tested
Biospecimen Collection, Cryocompression Therapy, Pneumatic Compression Therapy, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood, plasma, and serum

  • Cryocompression TherapyProcedure or surgery

    Undergo cryocompression

  • Pneumatic Compression TherapyProcedure or surgery

    Undergo continuous compression

  • Pneumatic Compression TherapyProcedure or surgery

    Undergo low cyclic compression

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05642611
Study groupRoleWhat they receive
Arm 1 (Cryocompression)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Cryocompression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm 2 (Continuous Compression)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Pneumatic Compression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm 3 (Low Cyclic Compression)Active comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Pneumatic Compression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Defined as an absolute increase of 8 or more points over baseline in the CIPN-20 sensory neuropathy subscale score. Analysis will be conducted multivariable logistic regression, adjusting for the baseline score and the stratification factor as covariates.

    Measured: At the 12-week assessment after randomization

Secondary outcomes (4)

  1. Mean sensory neuropathy scores

    Will assess by study arm. Will examine the CIPN-20 sensory neuropathy subscale score as a continuous variable on the 0-100 scale. The differences by intervention study arm at 12 weeks in changes from baseline in objective sensory and motor function tests (Neuorpen, tuning fork, Get Up and Go test) will also be compared. Multiple linear regression analysis will be conducted, adjusting for the baseline score and the stratification factor as covariates.

    Measured: At 12 weeks

  2. Dropouts

    Any dropouts prior to the week 12 assessment as failures. Since death is anticipated to be unrelated to the intervention assignment, deaths will be censored. Failures will be analyzed with an aggregate failure variable defined as: experience of neuropathy according to the CIPN-20 sensory neuropathy subscale score or dropout prior to week 12 (yes vs. no). Logistic regression will be used, adjusted for the stratification factor as a covariate.

    Measured: Prior to the week 12 assessment

  3. Trajectories over time

    Trajectories over time by intervention study arm in clinically meaningful CIPN will be compared. Generalized estimating equations with a logit link and robust standard errors will be used, adjusting for the baseline score and the stratification factor as covariates.

    Measured: 6, 12, 24, and 52 weeks

  4. Rates of adverse events

    Rates of adverse events related to study device (including cold intolerance, skin changes, other AEs as assessed by (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]) between the three interventions will be compared.

    Measured: At 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2022
  2. Study start6 Jun 2023
  3. Primary completion1 Aug 2030 (estimated)
  4. Study completion30 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
777 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05642611
Sponsor's protocol ID
S2205
Other IDs
NCI-2022-09251, SWOG-S2205, SWOG-S2205, SWOG-S2205, UG1CA189974
Acronym
ICE COMPRESS
Status last verified
Apr 2026
First submitted
30 Nov 2022
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Cryocompression Therapy and Pneumatic Compression Therapy in people with Malignant Solid Neoplasm, run by SWOG Cancer Research Network at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Justine Trevino (210-614-8808, jtrevino@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no) (time frame: At the 12-week assessment after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05642611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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