Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05642611
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2022-11-30
Brief Title:
Comparing Cooling andor Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Ice Compress Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICE COMPRESS
Brief 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 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 andor 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
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 andor 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 delaysdiscontinuation 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
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 andor 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 delaysdiscontinuation 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-09251 | REGISTRY | None | None |
| SWOG-S2205 | OTHER | None | None |
| SWOG-S2205 | OTHER | None | None |
| S2205 | OTHER | None | None |
| UG1CA189974 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189974 |