Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01261 | Other Identifier | National Cancer Institute | |
| WFBCCC 01119 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Low accruals
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
This trial studies how well cryocompression therapy works in reducing bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Peripheral neuropathy (nerve pain or tingling in hands or feet) is a common side effect of chemotherapy such as bortezomib that affects the quality of life and amount of chemotherapy that can be given to many cancer patients. Cryocompression is a treatment where a glove and a boot are worn to cool down the skin. This cooling treatment is safe and does not interfere with chemotherapy treatment. Daily cryocompression therapy may reduce neuropathy caused by bortezomib chemotherapy.
PRIMARY OBJECTIVES:
I. To assess the feasibility of daily cryocompression therapy in multiple myeloma patients with bortezomib-induced peripheral neuropathy (BIPN).
SECONDARY OBJECTIVES:
I. To examine the change in patient-reported assessment of neuropathy based on the sensory, motor and autonomic neuropathy scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Cancer-Induced Peripheral Neuropathy (CIPN20) (patient-reported outcome [PRO]) from baseline to 4 and 8 weeks after the start of cryocompression therapy.
II. To examine the change in physician graded assessment of peripheral neuropathy by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 criteria from baseline to 4 and 8 weeks after the start of cryocompression therapy.
III. To assess the effect on sensory and motor nerve function via nerve conduction study (NCS) (e.g. conduction velocity, latency, and amplitude) and neuro-ultrasound after 8 weeks of daily cryocompression therapy.
EXPLORATORY OBJECTIVES:
I. To explore the effect of 8 weeks of cryocompression on changes in digital artery perfusion as measured by ultrasound (US).
II. To examine the associations among the peripheral nerve assessment measures (nerve conduction and peripheral nerve US) with the patient reported outcomes (EORTC QLQ-CIPN20, PRO-CTCAE) at baseline, week 4, week 8, and for the change from baseline to week 8.
OUTLINE:
Patients undergo home cryocompression therapy treatments on their non-dominant hand and foot over 30 minutes daily for 8 weeks.
After completion of cryocompression therapy, patients are followed up at 30 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 VascuTherm5 vascular compression device | Experimental | VascuTherm5 vascular compression device Cohort 1 - Grade 2-3 neuropathy - Patients with established neuropathy (e.g. previously received bortezomib-based chemotherapy and have clinically documented CTCAE grade 2 or 3 neuropathies. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. |
|
| Cohort 2 VascuTherm5 vascular compression device | Experimental | VascuTherm5 vascular compression device Cohort 2 Grade 1-2 Neuropathy - Patients with new-onset neuropathy (e.g. currently receiving bortezomib-based chemotherapy have clinically documented CTCAE grade 1 or grade 2 neuropathy to explore its role in preventing worsening of CIPN in patients receiving neurotoxic chemotherapy. Patients undergo home cryocompression therapy treatments using VascuTherm device on their non-dominant hand and foot over 30 minutes daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VascuTherm5 vascular compression device | Device | VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Ability to complete daily 30-minute cryocompression treatments | The primary outcome measure will be feasibility of daily 30-minute cryocompression treatments with a target of 60% compliance. Compliance will be measured by VCU recorded data. Patient study treatment diary will be compared and when discrepancies exist, resolved either by asking the patient or discussing with the study principal investigator. Compliance is defined as completion of 60% of prescribed treatment days. Completion of at least 25 of 30 minutes on each day will be considered completion of therapy on the prescribed day. Analyses will be primarily descriptive to estimate variances and effect sizes for future work. The proportion of compliance and its 95% confidence interval will be calculated for each cohort. | Baseline up to 8 weeks of cryocompression therapy |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-CIPN20 Questionnaire | Chemotherapy-induced peripheral neuropathy (CIPN) is characterized by numbness, tingling, and shooting/burning pain. Patient-reported assessment of neuropathy based on sensory, motor and autonomic neuropathic pain scores (scale of 1 to 4) 1 being "not at all" and 4 being "very much." EORTC QLQ-CIPN20 (PRO) will be done at baseline, and at 4 and 8 weeks of cryocompression therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Velocity changes of digital artery perfusion | Pre-treatment and post-treatment velocity measurements (cm/s) will be measured by ultrasound at baseline and after 8 weeks of cryocompression therapy. | Baseline and after 8 weeks of cryocompression therapy |
| Proportion of Changes in Peripheral Nerve Function |
Inclusion Criteria:
Cohort 1: Patients with clinically documented CTCAE grade greater than or equal 2 neuropathy.
Cohort 2: Patients with clinically documented CTCAE grade 1-2 neuropathy.
• Currently or previously received bortezomib-containing regimen
Cohort 1: Patients who have previously received a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen.
Cohort 2: Patients who are currently receiving a bortezomib-containing regimen and have clinically documented neuropathy that is attributed to the bortezomib containing regimen.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roy Strowd, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2024 | Jun 28, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline up to 8 weeks of cryocompression therapy |
| NCI-CTCAE v5.0 Severity Grade Changes | Physician graded assessment of peripheral neuropathy as measured by NCI-CTCAE v5.0 criteria. The CTCAE displays Grades 1 through 5 (1 = mild, 5 = death) | Baseline up to 8 weeks of cryocompression therapy |
| Change in Motor Nerve Function | Tibial motor response will include tibial amplitude (mV), latency (sec) and conduction velocity (m/sec). Sural sensory response will include amplitude (mV) and latency (sec). Scores include N(normal), INC(increased), DEC(decreased), A(absent), or NA (not available) | Baseline and after 8 weeks of cryocompression therapy |
| Change in Sensory Response | Sural sensory response will include amplitude (mV) and latency (sec). Scores include N(normal), INC(increased), DEC(decreased), A(absent), or NA (not available) | Baseline and after 8 weeks of cryocompression therapy |
The peripheral nerve assessment measures with the patient reported outcomes (EORTC QLQ-CIPN20, PRO-CTCAE) at baseline, week 4, week 8, and for the change from baseline to week 8. Pain scores (scale of 1 to 4) 1 being "not at all" and 4 being "very much." |
| Baseline up to 8 weeks of cryocompression therapy |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |