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

NCT ID: NCT02111174

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-03-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Scrambler Therapy

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Sham Therapy

Intervention Type: DEVICE

Interventions

Scrambler Therapy

Intervention Type: DEVICE

Sham Therapy

Intervention Type: DEVICE

Other Intervention Names

MC5-A Calmare Therapy; Scrambler ST 5 TENS Device

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas J. Smith, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

SKCCC at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28257145 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

J1384

Identifier Type: OTHER

Identifier Source: secondary_id

NA_00086429

Identifier Type: OTHER

Identifier Source: secondary_id

J1384

Identifier Type: -

Identifier Source: org_study_id