NCT03870451 · REGISTRY CONDITION SEARCH

Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2026-10-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Feasibility - Ability to Complete Daily 30-minute Cryocompression Treatments

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outcome · POSTED

EORTC QLQ-CIPN20 Questionnaire

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outcome · POSTED

NCI-CTCAE v5.0 Severity Grade Changes

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outcome · POSTED

Change in Motor Nerve Function (Tibial Amplitude) From Baseline to 8 Weeks

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outcome · POSTED

Change in Motor Nerve Function (Latency) From Baseline to 8 Weeks

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outcome · POSTED

Change in Motor Nerve Function (Conduction Velocity) From Baseline to 8 Weeks

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outcome · POSTED

Sensory Response Evaluability at Baseline and 8 Weeks

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Device: VascuTherm5 vascular compression device
label
Cohort 1 VascuTherm5 vascular compression device
type
EXPERIMENTAL
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 Names
Device: VascuTherm5 vascular compression device
label
Cohort 2 VascuTherm5 vascular compression device
type
EXPERIMENTAL

interventions

arm Group Labels
Cohort 1 VascuTherm5 vascular compression device
Cohort 2 VascuTherm5 vascular compression device
description
VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
name
VascuTherm5 vascular compression device
type
DEVICE

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

DEVICE_FEASIBILITY

Enrollment

count: 18
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The primary outcome measure will be feasibility of daily 30-minute cryocompression treatments with a target of 60% compliance. Compliance will be measured with patient diaries. Only periods for which diaries exist will be evaluated. 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.
measure
Feasibility - Ability to Complete Daily 30-minute Cryocompression Treatments
time Frame
Baseline up to 8 weeks of cryocompression therapy

secondary Outcomes

description
Chemotherapy-induced peripheral neuropathy (CIPN) is characterized by numbness, tingling, and shooting/burning pain. Patient-reported assessment of neuropathy based on 19 questions from components of sensory, motor, and autonomic neuropathic. Question responses are (scale of 1 to 4) 1 being "not at all" and 4 being "very much." The total EORTC score (calculated as the average of the component responses) (range 1-4) and then converted to a 100 point scale (range 0-100) with higher scores having more severe symptoms or greater functional limitation. EORTC QLQ-CIPN20 (PRO) will be done at baseline, and at 4 and 8 weeks of cryocompression therapy.
measure
EORTC QLQ-CIPN20 Questionnaire
time Frame
Baseline, 4 weeks, 8 weeks
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)
measure
NCI-CTCAE v5.0 Severity Grade Changes
time Frame
Baseline, 4 weeks, 8 weeks
description
Change in tibial motor response from baseline to 8 weeks will include tibial amplitude (mV)
measure
Change in Motor Nerve Function (Tibial Amplitude) From Baseline to 8 Weeks
time Frame
Baseline, 8 weeks
description
Change in Tibial motor response from baseline to 8 weeks will include latency (ms)
measure
Change in Motor Nerve Function (Latency) From Baseline to 8 Weeks
time Frame
Baseline, 8 weeks
description
Change in tibial motor response from baseline to 8 weeks will include conduction velocity (m/sec).
measure
Change in Motor Nerve Function (Conduction Velocity) From Baseline to 8 Weeks
time Frame
Baseline, 8 weeks
description
Sural sensory response (collected as yes/no) measured on both the left and right ankles at baseline and 8 weeks for amplitude, onset latency, and peak latency. Reported are the number with sural sensory response measured (yes).
measure
Sensory Response Evaluability at Baseline and 8 Weeks
time Frame
Baseline, 8 weeks

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice