Back to resultsCryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma
Primary Purpose
Chemotherapy-induced Peripheral Neuropathy, Plasma Cell Myeloma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VascuTherm5 vascular compression device
Sponsored by
About this trial
This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed multiple myeloma (any International Staging System [ISS] stage).
- Clinical symptoms of bortezomib-induced peripheral neuropathy as measured by the NCI-CTCAE.
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.
- Age must be greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) =< 4.
- Life expectancy >= 6 months.
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.
Exclusion Criteria:
- Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of bortezomib therapy.
- Other explanatory etiology for neuropathy.
- Presumptive evidence of congestive heart failure.
- Current deep vein thrombosis or pulmonary embolism (diagnosed within the past 6 months).
- Current pulmonary edema.
- Unable to provide accurate medical history.
- Pregnant women are excluded from this study because they will not be receiving myeloma standard of care (SOC) therapy or bortezomib-based therapy per inclusion criteria.
- Current or previously documented inflammatory phlebitis; thrombophlebitis; decompensated cardiac insufficiency; arterial dysregulation; erysipelas; carcinoma or carcinoma metastasis in the affected extremity; decompensated hypotonia; venous or arterial occlusive disease; or Raynaud's disease;
- Current monoclonal gammopathy of undetermined significance (MGUS), Waldenstroms macroglobulinemia, or Castleman disease.
Sites / Locations
- Wake Forest Baptist Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1 VascuTherm5 vascular compression device
Cohort 2 VascuTherm5 vascular compression device
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
60% Compliance with therapy
The primary outcome measure will be feasibility of daily 30-minute cryocompression treatments with a target of 60% compliance. Compliance will be measured by vascular compression unit recorded data. Patient study treatment diary will also be compared and when discrepancies exist, resolved either by asking the patient or discussing with the Study PI. 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.
Secondary Outcome Measures
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.
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)
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)
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)
Full Information
NCT ID
NCT03870451
First Posted
March 5, 2019
Last Updated
May 4, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03870451
Brief Title
Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma
Official Title
Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Plasma Cell Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 VascuTherm5 vascular compression device
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2 VascuTherm5 vascular compression device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VascuTherm5 vascular compression device
Intervention Description
VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
Primary Outcome Measure Information:
Title
60% Compliance with therapy
Description
The primary outcome measure will be feasibility of daily 30-minute cryocompression treatments with a target of 60% compliance. Compliance will be measured by vascular compression unit recorded data. Patient study treatment diary will also be compared and when discrepancies exist, resolved either by asking the patient or discussing with the Study PI. 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.
Time Frame
Baseline up to 8 weeks of cryocompression therapy
Secondary Outcome Measure Information:
Title
EORTC QLQ-CIPN20 Questionnaire
Description
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.
Time Frame
Baseline up to 8 weeks of cryocompression therapy
Title
NCI-CTCAE v5.0 Severity Grade Changes
Description
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)
Time Frame
Baseline up to 8 weeks of cryocompression therapy
Title
Change in Motor Nerve Function
Description
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)
Time Frame
Baseline and after 8 weeks of cryocompression therapy
Title
Change in Sensory Response
Description
Sural sensory response will include amplitude (mV) and latency (sec). Scores include N(normal), INC(increased), DEC(decreased), A(absent), or NA (not available)
Time Frame
Baseline and after 8 weeks of cryocompression therapy
Other Pre-specified Outcome Measures:
Title
Velocity changes of digital artery perfusion
Description
Pre-treatment and post-treatment velocity measurements (cm/s) will be measured by ultrasound at baseline and after 8 weeks of cryocompression therapy.
Time Frame
Baseline and after 8 weeks of cryocompression therapy
Title
Proportion of Changes in Peripheral Nerve Function
Description
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."
Time Frame
Baseline up to 8 weeks of cryocompression therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically or cytologically confirmed multiple myeloma (any International Staging System [ISS] stage).
Clinical symptoms of bortezomib-induced peripheral neuropathy as measured by the NCI-CTCAE.
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.
Age must be greater than or equal to 18 years.
Eastern Cooperative Oncology Group (ECOG) =< 4.
Life expectancy >= 6 months.
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.
Exclusion Criteria:
Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of bortezomib therapy.
Other explanatory etiology for neuropathy.
Presumptive evidence of congestive heart failure.
Current deep vein thrombosis or pulmonary embolism (diagnosed within the past 6 months).
Current pulmonary edema.
Unable to provide accurate medical history.
Pregnant women are excluded from this study because they will not be receiving myeloma standard of care (SOC) therapy or bortezomib-based therapy per inclusion criteria.
Current or previously documented inflammatory phlebitis; thrombophlebitis; decompensated cardiac insufficiency; arterial dysregulation; erysipelas; carcinoma or carcinoma metastasis in the affected extremity; decompensated hypotonia; venous or arterial occlusive disease; or Raynaud's disease;
Current monoclonal gammopathy of undetermined significance (MGUS), Waldenstroms macroglobulinemia, or Castleman disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Mabe, RN
Phone
336-713-6928
Email
bmabe@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Strowd, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma
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