Chemotherapy-induced Peripheral NeuropathyNCT03870451
Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma
A study testing VascuTherm5 vascular compression device in people with Chemotherapy-induced Peripheral Neuropathy and Plasma Cell Myeloma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Plasma Cell Myeloma
- What is being tested?
- VascuTherm5 vascular compression device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of daily cryocompression therapy in multiple myeloma patients with bortezomib-induced peripheral neuropathy (BIPN).
SECONDARY OBJECTIVES:
- 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:
- 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.
- Being tested
- VascuTherm5 vascular compression device
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VascuTherm5 vascular compression deviceDevice
VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VascuTherm5 vascular compression device |
| 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. Receives: Device: VascuTherm5 vascular compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: Baseline up to 8 weeks of cryocompression therapy
Secondary outcomes (6)
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 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.
Measured: Baseline, 4 weeks, 8 weeks
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)
Measured: Baseline, 4 weeks, 8 weeks
Change in Motor Nerve Function (Tibial Amplitude) From Baseline to 8 Weeks
Change in tibial motor response from baseline to 8 weeks will include tibial amplitude (mV)
Measured: Baseline, 8 weeks
Change in Motor Nerve Function (Latency) From Baseline to 8 Weeks
Change in Tibial motor response from baseline to 8 weeks will include latency (ms)
Measured: Baseline, 8 weeks
Change in Motor Nerve Function (Conduction Velocity) From Baseline to 8 Weeks
Change in tibial motor response from baseline to 8 weeks will include conduction velocity (m/sec).
Measured: Baseline, 8 weeks
Sensory Response Evaluability at Baseline and 8 Weeks
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).
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Nov 2019
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Why it stopped: Low accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roy Strowd, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870451
- Sponsor's protocol ID
- IRB00056641
- Other IDs
- NCI-2019-01261, WFBCCC 01119, P30CA012197
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2019
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT03870451
- Acronym / sponsor ID
- IRB00056641
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accruals
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Posted 13 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the feasibility of daily cryocompression therapy in multiple myeloma patients with bortezomib-induced peripheral neuropathy (BIPN).
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 VascuTherm5 vascular compression device | Experimental | Device: VascuTherm5 vascular compression deviceVascuTherm5 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 | Device: VascuTherm5 vascular compression deviceVascuTherm5 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VascuTherm5 vascular compression deviceVascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device | Device | Cohort 1 VascuTherm5 vascular compression device, Cohort 2 VascuTherm5 vascular compression device |
Primary outcome
Feasibility - Ability to Complete Daily 30-minute Cryocompression Treatments
Time frame: Baseline up to 8 weeks of cryocompression therapy
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.
6 secondary outcomes
EORTC QLQ-CIPN20 Questionnaire
Time frame: Baseline, 4 weeks, 8 weeks
NCI-CTCAE v5.0 Severity Grade Changes
Time frame: Baseline, 4 weeks, 8 weeks
Change in Motor Nerve Function (Tibial Amplitude) From Baseline to 8 Weeks
Time frame: Baseline, 8 weeks
Change in Motor Nerve Function (Latency) From Baseline to 8 Weeks
Time frame: Baseline, 8 weeks
Change in Motor Nerve Function (Conduction Velocity) From Baseline to 8 Weeks
Time frame: Baseline, 8 weeks
Sensory Response Evaluability at Baseline and 8 Weeks
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Strowd, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VascuTherm5 vascular compression device in people with Chemotherapy-induced Peripheral Neuropathy and Plasma Cell Myeloma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Ability to Complete Daily 30-minute Cryocompression Treatments (time frame: Baseline up to 8 weeks of cryocompression therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.