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Cryocompression Therapy for Multiple Myeloma
N/A
Waitlist Available
Led By Roy Strowd, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed multiple myeloma (any International Staging System [ISS] stage)
Eastern Cooperative Oncology Group (ECOG) =< 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 8 weeks of cryocompression therapy
Awards & highlights
Study Summary
This trial studies the effect of cryocompression therapy on reducing bortezomib-induced peripheral neuropathy in patients with multiple myeloma.
Who is the study for?
This trial is for adults with multiple myeloma who have nerve pain or tingling from bortezomib chemotherapy. They must have a life expectancy of at least 6 months and be able to give informed consent. People with certain heart, blood vessel, or other unrelated neuropathy causes, or pregnant women cannot join.Check my eligibility
What is being tested?
The trial tests cryocompression therapy using the VascuTherm5 device to reduce nerve pain in hands and feet caused by bortezomib in multiple myeloma patients. It involves wearing a cooling glove and boot that don't interfere with chemotherapy.See study design
What are the potential side effects?
Cryocompression therapy is generally safe but may cause discomfort due to cold temperatures, potential skin irritation where the device is applied, and temporary numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma at any stage.
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I am mostly bedridden but can still take care of my personal needs.
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I am on a bortezomib regimen and have neuropathy due to it.
Select...
I experience numbness or pain in my hands and feet from previous treatments.
Select...
I have neuropathy from previous bortezomib treatment.
Select...
I am 18 years old or older.
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I have moderate to severe nerve pain or damage.
Select...
I have been treated with a medication that includes bortezomib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 8 weeks of cryocompression therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 8 weeks of cryocompression therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
60% Compliance with therapy
Secondary outcome measures
Change in Motor Nerve Function
Change in Sensory Response
EORTC QLQ-CIPN20 Questionnaire
+1 moreOther outcome measures
Proportion of Changes in Peripheral Nerve Function
Velocity changes of digital artery perfusion
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 VascuTherm5 vascular compression deviceExperimental Treatment1 Intervention
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.
Group II: Cohort 1 VascuTherm5 vascular compression deviceExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,219 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
20 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,529 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Roy Strowd, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple myeloma at any stage.I am mostly bedridden but can still take care of my personal needs.You are expected to live for at least 6 more months.I am on a bortezomib regimen and have neuropathy due to it.I have signs of heart failure.I experience numbness or pain in my hands and feet from previous treatments.I have neuropathy from previous bortezomib treatment.I am 18 years old or older.I am not pregnant, as pregnant women cannot participate.There is another reason for your nerve pain.I have MGUS, Waldenstrom's macroglobulinemia, or Castleman disease.I have moderate to severe nerve pain or damage.I have had issues like severe vein inflammation, heart problems, skin infections, cancer spread, very low blood pressure, blocked blood vessels, or Raynaud's disease.You have mild to moderate nerve damage as determined by your doctor.I have been treated with a medication that includes bortezomib.I had nerve damage in my hands or feet before starting bortezomib treatment.I have had a blood clot in my leg or lung in the last 6 months.I have fluid in my lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 VascuTherm5 vascular compression device
- Group 2: Cohort 2 VascuTherm5 vascular compression device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any participatory opportunities for individuals in this trial?
"Yes, according to clinicaltrials.gov the study is actively recruiting participants. It was first posted on November 1st 2019 and most recently modified on September 12th 2022. The trial requires 24 people from a single location for enrollment."
Answered by AI
How many participants is the team looking to enroll for this research?
"Affirmative. The information on clinicaltrials.gov confirms that this medical study, initiated in November 2019, is still recruiting patients. 24 people must be enrolled from 1 location."
Answered by AI
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