Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
NCT ID: NCT05642611
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
777 participants
INTERVENTIONAL
2023-06-06
2031-08-30
Brief Summary
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Detailed Description
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I. 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:
I. 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.
V. 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:
I. 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).
V. 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.
X. 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:
I. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm 1 (Cryocompression)
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.
Biospecimen Collection
Undergo collection of blood, plasma, and serum
Cryocompression Therapy
Undergo cryocompression
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm 2 (Continuous Compression)
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.
Biospecimen Collection
Undergo collection of blood, plasma, and serum
Pneumatic Compression Therapy
Undergo continuous compression
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm 3 (Low Cyclic Compression)
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.
Biospecimen Collection
Undergo collection of blood, plasma, and serum
Pneumatic Compression Therapy
Undergo low cyclic compression
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood, plasma, and serum
Cryocompression Therapy
Undergo cryocompression
Pneumatic Compression Therapy
Undergo continuous compression
Pneumatic Compression Therapy
Undergo low cyclic compression
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Melissa K Accordino
Role: PRINCIPAL_INVESTIGATOR
SWOG - Columbia University
Katherine Pennington, MD
Role: PRINCIPAL_INVESTIGATOR
NRG - University of Washington
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
CaroMont Regional Medical Center
Gastonia, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union
Union, South Carolina, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Other Identifiers
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NCI-2022-09251
Identifier Type: REGISTRY
Identifier Source: secondary_id
SWOG-S2205
Identifier Type: OTHER
Identifier Source: secondary_id
SWOG-S2205
Identifier Type: OTHER
Identifier Source: secondary_id
SWOG-S2205
Identifier Type: OTHER
Identifier Source: secondary_id
S2205
Identifier Type: -
Identifier Source: org_study_id
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