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Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02111174
First Posted: April 11, 2014
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose

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.


Condition Intervention
Neuropathy Device: Scrambler Therapy Device: Sham Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: March 2015
Study Completion Date: March 24, 2017
Primary Completion Date: March 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • MC5-A Calmare Therapy
  • Scrambler ST 5 TENS Device
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18 years of age or older with cancer
  • English speakers
  • Lower extremity CIPN neuropathy: Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezimib).
  • Pain or symptoms of lower extremity peripheral neuropathy of >3 month's duration attributed to chemotherapy-induced peripheral neuropathy
  • An average daily pain rating of > 4 out of 10
  • Life expectancy >3 months
  • ECOG Performance Status 0, 1, 2, or 3
  • Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form

Exclusion Criteria:

  • Any of the following: pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.).
  • Use of an investigational agent for pain control concurrently or within the past 30 days
  • History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation
  • Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
  • Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates. (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed)
  • Patients with a history of myocardial infarction or ischemic heart disease within the past six months
  • Patients with history of epilepsy, brain damage, or symptomatic brain metastases
  • Prior celiac plexus block, or other neurolytic pain control treatment
  • Other identified causes of painful parasthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: e.g., carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) that might be responsible for the patient's current neuropathic symptoms
  • Skin conditions such as open sores that would prevent proper application of the electrodes
  • Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
  • Currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin (Neurontin) or pregabalin (Lyrica). Because of data that support that patients do not do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off them prior to study initiation. The study team will provide instructions on how to do this
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111174


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287-0013
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Thomas J. Smith, MD, FACP SKCCC at Johns Hopkins
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02111174     History of Changes
Other Study ID Numbers: J1384
J1384 ( Other Identifier: SKCCC at Johns Hopkins )
NA_00086429 ( Other Identifier: JHMIRB )
First Submitted: March 23, 2014
First Posted: April 11, 2014
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Neuropathy
Peripheral neuropathy
Chemotherapy-induced peripheral neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases


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