Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chemotherapy Induced Peripheral Neuropathy
  • Plasma Cell Myeloma
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 n...

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.

Tracking Information

NCT #
NCT03870451
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Roy Strowd, MD Wake Forest University Health Sciences