Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma

NCT ID: NCT03870451

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-02-10

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Plasma Cell Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Cohort 1 VascuTherm5 vascular compression device

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.

Group Type: EXPERIMENTAL

VascuTherm5 vascular compression device

Intervention Type: DEVICE

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

Cohort 2 VascuTherm5 vascular compression device

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 Type: EXPERIMENTAL

VascuTherm5 vascular compression device

Intervention Type: DEVICE

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

Interventions

VascuTherm5 vascular compression device

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

Intervention Type: DEVICE

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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy Strowd, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2019-01261

Identifier Type: OTHER

Identifier Source: secondary_id

WFBCCC 01119

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00056641

Identifier Type: -

Identifier Source: org_study_id