Cryocompression Therapy for Peripheral Neuropathy in Patients With Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    24
  • sponsor
    Wake Forest University Health Sciences
Updated on 21 April 2022
cancer
multiple myeloma
chemotherapy regimen
bortezomib
paresthesia
peripheral neuropathy

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.

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.

Details
Condition Chemotherapy-induced Peripheral Neuropathy, Plasma Cell Myeloma
Treatment VascuTherm5 vascular compression device
Clinical Study IdentifierNCT03870451
SponsorWake Forest University Health Sciences
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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
Eastern Cooperative Oncology Group (ECOG) =< 4
Age must be greater than or equal to 18 years
Ability to understand and the willingness to sign an Institutional Review Board
(IRB)-approved informed consent document
Life expectancy >= 6 months

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
Current pulmonary edema
months)
Unable to provide accurate medical history
Pregnant women are excluded from this study because they will not be receiving myeloma
standard of care (SOC) therapy or bortezomib-based therapy per inclusion criteria
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
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