NeuropathyNCT02111174
Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
A study testing Scrambler Therapy in people with Neuropathy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy
- What is being tested?
- Scrambler Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 24 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-0013
About this study
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)
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.
Read more
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
- Being tested
- Scrambler Therapy, Sham Therapy
- Keywords
- Neuropathy, Peripheral neuropathy, Chemotherapy-induced peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scrambler TherapyDevice
Also called MC5-A Calmare Therapy, Scrambler ST 5 TENS Device
Sham TherapyDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 28 days
Secondary outcomes (10)
Change in Pain at 2 Months as Measured by the Modified Brief Pain Index
To determine the change in pain from day 0 to 2 months (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.
Measured: Change from baseline to 2 months
Change in Pain at 3 Months as Measured by the Modified Brief Pain Index
To determine the change in pain from day 0 to 3 months (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.
Measured: Change from baseline to 3 months
Changes in Patient Reported Sensory Outcomes at 28 Days
This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.
Measured: Change from baseline to 28 days
Changes in Patient Reported Sensory Outcomes at 2 Months
This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.
Measured: Change from baseline to 2 months
Changes in Patient Reported Sensory Outcomes at 3 Months
This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.
Measured: Change from baseline to 3 months
Changes in Patient Reported Motor Outcomes at 28 Days
This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.
Measured: Change from baseline to 28 days
Changes in Patient Reported Motor Outcomes at 2 Months
This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.
Measured: Change from baseline to 2 months
Changes in Patient Reported Motor Outcomes at 3 Months
This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.
Measured: Change from baseline to 3 months
Number of Patients Who Stopped Using Opioids at 28 Days
This will be assessed by concomitant medication review by a study team member during the 10 days of treatment. Follow-up was assessed as participant self-report over the last 10 days; all opiates were further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.
Measured: 28 days post-intervention
Number of Patients Who Stopped Using Neuroleptics at 28 Days
This will be assessed by concomitant medication review by a study team member during the 10 days of treatment. Follow-up was assessed as participant self-report over the last 10 days; all opiates were further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.
Measured: 28 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMar 2015
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas J. Smith, MD, FACP, Principal investigator, SKCCC at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111174
- Sponsor's protocol ID
- J1384
- Other IDs
- J1384, NA_00086429
- Status last verified
- Jul 2018
- First submitted
- 23 Mar 2014
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28257145
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02111174
- Acronym / sponsor ID
- J1384
- Conditions
- Neuropathy
- Keywords
- Neuropathy, Peripheral neuropathy, Chemotherapy-induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Posted 17 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scrambler Therapy | Experimental | Device: Scrambler TherapyThe 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. |
| Sham Therapy | Sham comparator | Device: Sham TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scrambler TherapyAlso: MC5-A Calmare Therapy, Scrambler ST 5 TENS Device | Device | Scrambler Therapy |
| Sham Therapy | Device | Sham Therapy |
Primary outcome
Change in Pain as Measured by the Modified Brief Pain Index at 28 Days
Time frame: Change from baseline to 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.
10 secondary outcomes
Change in Pain at 2 Months as Measured by the Modified Brief Pain Index
Time frame: Change from baseline to 2 months
Change in Pain at 3 Months as Measured by the Modified Brief Pain Index
Time frame: Change from baseline to 3 months
Changes in Patient Reported Sensory Outcomes at 28 Days
Time frame: Change from baseline to 28 days
Changes in Patient Reported Sensory Outcomes at 2 Months
Time frame: Change from baseline to 2 months
Changes in Patient Reported Sensory Outcomes at 3 Months
Time frame: Change from baseline to 3 months
Changes in Patient Reported Motor Outcomes at 28 Days
Time frame: Change from baseline to 28 days
Changes in Patient Reported Motor Outcomes at 2 Months
Time frame: Change from baseline to 2 months
Changes in Patient Reported Motor Outcomes at 3 Months
Time frame: Change from baseline to 3 months
Number of Patients Who Stopped Using Opioids at 28 Days
Time frame: 28 days post-intervention
Number of Patients Who Stopped Using Neuroleptics at 28 Days
Time frame: 28 days post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28257145Cathcart-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J. Smith, MD, FACP principal investigator
SKCCC at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scrambler Therapy in people with Neuropathy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain as Measured by the Modified Brief Pain Index at 28 Days (time frame: Change from baseline to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.