MC-5A for Chemotherapy Induced Peripheral Neuropathy

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Neuropathy, Paraneoplastic

Treatments: Drug: Sham device; Device: MC-5A

Study type: Interventional

Funder types: Other

Identifiers

NCT01261780

NCI-2012-00075 (Registry Identifier)

A534260 (Other Identifier)

2010-0361 (Other Identifier)

SMPH\MEDICINE\HEM-ONC (Other Identifier)

OS10328

Details and patient eligibility

About

Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer therapy with few treatment options. CIPN is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients.

The purpose of this study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• painful peripheral neuropathy resulting from chemotherapy
• pain must be present for minimum of 6 months
• must be able to read/understand English
• stable analgesics regimens allowed (no change for past 7 days)

Exclusion criteria

• painful peripheral neuropathy that is not the result of chemotherapy
• pregnant women
• patients unable to wean off anti-epileptics
• patients currently receiving chemotherapy known to cause peripheral neuropathy
• patients with pacemakers or implanted defibrillators
• patients with vena cava or aneurysm clips
• patients with a history of epilepsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14 participants in 2 patient groups

Sham device

Sham Comparator group

Description:

Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days

Treatment:

Drug: Sham device

MC-5A treatment

Active Comparator group

Description:

MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.

Treatment:

Device: MC-5A