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Cryocompression Therapy for Multiple Myeloma

Q: Are there any participatory opportunities for individuals in this trial?

<p>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.</p>

Q: How many participants is the team looking to enroll for this research?

<p>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.</p>

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 below

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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.

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I experience numbness or pain in my hands and feet from previous treatments.

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I have neuropathy from previous bortezomib treatment.

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I am 18 years old or older.

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I have moderate to severe nerve pain or damage.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 8 weeks of cryocompression therapy for reporting.

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 more

Other 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.

0 / 8Eligibility criteria met

Find a Location

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

Cryocompression Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03870451 — N/A

Peripheral Neuropathy Research Study Groups: Cohort 1 VascuTherm5 vascular compression device, Cohort 2 VascuTherm5 vascular compression device

Peripheral Neuropathy Clinical Trial 2023: Cryocompression Therapy Highlights & Side Effects. Trial Name: NCT03870451 — N/A

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

Recent research and studies

clinicaltrials.govStudy

Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma

2019. "Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03870451.

All > Neuropathy > Peripheral Neuropathy