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

NCT02111174 | Completed Results

• 2 other identifiers: J1384NA_00086429
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuropathy

Keywords

Neuropathy; Peripheral neuropathy; Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in Pain as Measured by the Modified Brief Pain Index at 28 Days

  To determine the change in pain from day 0 to day 28 (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The 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 with higher scores indicating more pain. A negative score for the change in pain indicates improvement.

  Change from baseline to 28 days

Secondary Outcomes (10)

• Change in Pain at 2 Months as Measured by the Modified Brief Pain Index

  Change from baseline to 2 months

• Change in Pain at 3 Months as Measured by the Modified Brief Pain Index

  Change from baseline to 3 months

• Changes in Patient Reported Sensory Outcomes at 28 Days

  Change from baseline to 28 days

• Changes in Patient Reported Sensory Outcomes at 2 Months

  Change from baseline to 2 months

• Changes in Patient Reported Sensory Outcomes at 3 Months

  Change from baseline to 3 months

Study Arms (2)

Scrambler Therapy

EXPERIMENTAL

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 Therapy

SHAM COMPARATOR

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

Interventions

Scrambler Therapy DEVICE

Also known as: MC5-A Calmare Therapy, Scrambler ST 5 TENS Device

Scrambler Therapy

Sham Therapy DEVICE

Sham Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-0013, United States

Location

Related Publications (1)

• Cathcart-Rake EJ, Hilliker DR, Loprinzi CL. Chemotherapy-induced neuropathy: Central resolution of a peripherally perceived problem? Cancer. 2017 Jun 1;123(11):1898-1900. doi: 10.1002/cncr.30650. Epub 2017 Mar 3. No abstract available.

  PMID: 28257145 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Thomas Smith, M.D.
• Organization: Johns Hopkins SKCCC

tsmit136@jhmi.edu

410-955-2091

Study Officials

• Thomas J. Smith, MD, FACP

  SKCCC at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2015
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: August 17, 2018
• Results First Posted: August 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)