- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05642611
Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy (ICE COMPRESS)
Ice Compress: Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Mariah Norman
- Phone Number: 210-614-8808
- Email: mnorman@swog.org
Study Contact Backup
- Name: Justine Trevino
- Phone Number: 210-614-8808
- Email: jtrevino@swog.org
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University
-
Contact:
- Melissa K Accordino, MD
- Phone Number: 212-305-8615
- Email: mkg2134@cumc.columbia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo collection of blood, plasma, and serum
Other Names:
Undergo cryocompression
|
Experimental: 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.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo collection of blood, plasma, and serum
Other Names:
Undergo continuous compression
Undergo low cyclic compression
|
Active Comparator: 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.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo collection of blood, plasma, and serum
Other Names:
Undergo continuous compression
Undergo low cyclic compression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no)
Time Frame: At the 12-week assessment after randomization
|
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.
|
At the 12-week assessment after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean sensory neuropathy scores
Time Frame: At 12 weeks
|
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.
|
At 12 weeks
|
Dropouts
Time Frame: Prior to the week 12 assessment
|
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.
|
Prior to the week 12 assessment
|
Trajectories over time
Time Frame: 6, 12, 24, and 52 weeks
|
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.
|
6, 12, 24, and 52 weeks
|
Rates of adverse events
Time Frame: At 12 weeks
|
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.
|
At 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa K Accordino, SWOG - Columbia University
- Principal Investigator: Katherine Pennington, MD, NRG - University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2205 (Other Identifier: CTEP)
- UG1CA189974 (U.S. NIH Grant/Contract)
- NCI-2022-09251 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- SWOG-S2205 (Other Identifier: DCP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malignant Solid Neoplasm
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingLocally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States, Puerto Rico
-
University of California, San FranciscoCompletedIntegrative Palliative Care/Psycho-Oncology Telehealth Intervention in Patients With Advanced CancerAdvanced Malignant Solid Neoplasm | Locally Advanced Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterTerminatedLocally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States, Canada
Clinical Trials on Quality-of-Life Assessment
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Malignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChildhood Malignant NeoplasmUnited States, Canada, Puerto Rico, Australia, New Zealand
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Breast Carcinoma | Head and Neck Carcinoma | Lung Carcinoma | Esophageal Carcinoma | Malignant Digestive System Neoplasm | Malignant Central Nervous System Neoplasm | Genitourinary System CarcinomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBreast Carcinoma | Cancer SurvivorUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedFallopian Tube Cancer | Recurrent Endometrial Carcinoma | Stage IV Ovarian Epithelial Cancer | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Recurrent Uterine Sarcoma | Stage III Uterine Sarcoma | Stage IV Uterine Sarcoma | Recurrent Ovarian Epithelial Cancer | Stage IV Endometrial Carcinoma | Ovarian... and other conditionsUnited States
-
Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States