NCT03870451

Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma

Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	VascuTherm5 vascular compression device	VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2019-03-12
• Last updated: 2024-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study