Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will relieve chemotherapy induced peripheral neuropathy (CIPN).
Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy machine directs electrical signals across the field to simulate non-pain information.
Based on other studies, we think that we relieve pain with the Scrambler therapy device, but it has not been tested in a setting such as this one. This means that some of the pain relief could be due to placebo effect, or the CIPN pain going away on its own. In this study we want to compare the Scrambler Therapy with the sham therapy (the therapy that does not use the electrical signals). We hope that this study will help us determine if the Scrambler device really helps patients with CIPN.
Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for at least 3 months may be eligible to join this study.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||A Pilot Randomized Sham-Controlled Trial of MC5-A Calmare Therapy (Scrambler Therapy) in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)|
- Change in pain as measured by the Modified Brief Pain Index [ Time Frame: Baseline and 28 days ]To determine the change in pain from day 0 to day 28 (as measured by the Modified Brief Pain Index, question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN).
- Changes in the complete Brief Pain Inventory score [ Time Frame: Baseline and 28 days ]The Brief Pain Inventory (BPI) short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales.
- Changes in patient reported outcomes [ Time Frame: Baseline and 28 days ]This will be assessed using the EORTC QLQ-CIPN20, a CIPN-specific questionnaire which includes three scales assessing sensory, motor, and autonomic symptoms and functioning with each item measured on a 1-4 scale.
- Changes in pain drug use [ Time Frame: Baseline and 28 days ]This will be assessed by concomitant medication review by a study team member; all opiates will be further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Scrambler Therapy
The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.
Device: Scrambler Therapy
Sham Comparator: Sham Therapy
The device is a cutaneous electrical stimulator that uses electrodes placed on the skin similar to an electrocardiogram (EKG) machine, feeling similar to a tingling or bee-sting like sensation during the therapy. The electrodes are placed in areas not thought to help relieve pain associated with chemotherapy-induced peripheral neuropathy.
|Device: Sham Therapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02111174
|Contact: Thomas J. Smith, MD, FACP||410-955-2091 ext email@example.com|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21287-0013|
|Contact: Johns Hopkins Clinical Trials Specialist 410-955-8804|
|Principal Investigator: Thomas J. Smith, MD, FACP|
|Principal Investigator:||Thomas J. Smith, MD, FACP||SKCCC at Johns Hopkins|