NCT03870451

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

3.3 years

First QC Date

March 5, 2019

Last Update Submit

October 23, 2024

Conditions

Chemotherapy-induced Peripheral NeuropathyPlasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 by VCU recorded data. Patient study treatment diary will be compared and when discrepancies exist, resolved either by asking the patient or discussing with the study principal investigator. 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.

    Baseline up to 8 weeks of cryocompression therapy

Secondary Outcomes (4)

  • EORTC QLQ-CIPN20 Questionnaire

    Baseline up to 8 weeks of cryocompression therapy

  • NCI-CTCAE v5.0 Severity Grade Changes

    Baseline up to 8 weeks of cryocompression therapy

  • Change in Motor Nerve Function

    Baseline and after 8 weeks of cryocompression therapy

  • Change in Sensory Response

    Baseline and after 8 weeks of cryocompression therapy

Other Outcomes (2)

  • Velocity changes of digital artery perfusion

    Baseline and after 8 weeks of cryocompression therapy

  • Proportion of Changes in Peripheral Nerve Function

    Baseline up to 8 weeks of cryocompression therapy

Study Arms (2)

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.

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.

Device: VascuTherm5 vascular compression device

Interventions

VascuTherm5 vascular compression deviceDEVICE

VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device

Cohort 1 VascuTherm5 vascular compression deviceCohort 2 VascuTherm5 vascular compression device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Roy Strowd, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 12, 2019

Study Start

November 1, 2019

Primary Completion

February 10, 2023

Study Completion

February 10, 2023

Last Updated

October 26, 2024

Record last verified: 2024-10

Locations

US(1)