A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer
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ClinicalTrials.gov Identifier: NCT03707444 |
Recruitment Status :
Withdrawn
(The PI is dealing with recurrent cancer and multiple side effects of treatment. N o one else to do the study.)
First Posted : October 16, 2018
Last Update Posted : November 29, 2019
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Condition or disease | Intervention/treatment |
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Cancer Pancreas Pain Syndrome Cancer Related Pain | Device: Scrambler Therapy Device |

Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer |
Actual Study Start Date : | October 1, 2018 |
Estimated Primary Completion Date : | October 31, 2019 |
Estimated Study Completion Date : | November 26, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
Scrambler Therapy
All participants get the same device treatment with the Scrambler Therapy device, up to 10 treatments.
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Device: Scrambler Therapy Device
Superficial neuromodulation using EKG type electrodes [Scrambler (MC5-A Calmare) Therapy] |
- Change in Average pain as assessed by Brief Pain Inventory Question 3 [ Time Frame: Day 0, Day 28 ]Change in average pain will be evaluated using the Brief Pain Inventory Question 3. This is scored from 0 to 10 with 0 being no pain and 10 being worst pain.
- Change in Pain as assessed by Brief Pain Inventory [ Time Frame: Day 0, Day 28 ]The change in pain will be assessed by the standard Brief Pain Inventory which has 35 items with an overall scoring of 0 to 10. A score of 0 means no pain and a score of 10 means worst pain.
- Change in opioid use [ Time Frame: Day 0, Day 28 ]The amount of opioids in milligrams used between day 0 and day 28 will be converted to morphine equivalents to assess any change in the amount of opioid used.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Men and women 18 years of age or older with cancer
- English speakers
- Documented pancreas cancer by cytology or histology
- Pain in the abdomen with an average daily pain rating of > 46 out of 10, using the BPI
- A life expectancy > 5 days, so that some treatments can be given)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2, 3, or 4
- The patient must be able to understand the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Exclusion Criteria:
- 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
- Receipt of radiation to the abdomen for any reason during the planned 10-day treatment time
- 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).
- 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
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Skin conditions such as open sores that would prevent proper application of the electrodes; or other condition(s) that in the opinion of the investigators might compromise the objectives of the study.
- Patients currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin (Neurontin) or pregabalin (Lyrica) will be tapered off these medications over 7 days because of new data that suggests patients do not do as well when on gabapentin or pregabalin. The study team will provide instructions on how to do this.

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): NCT03707444
United States, Maryland | |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Thomas J Smith, MD | Johns Hopkins Sidney Kimmel COmprehensive Cancer Center |
Other Publications:
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT03707444 |
Obsolete Identifiers: | NCT03322007 |
Other Study ID Numbers: |
J15120 IRB00063416 ( Other Identifier: Johns Hopkins IRB ) |
First Posted: | October 16, 2018 Key Record Dates |
Last Update Posted: | November 29, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Pancreatic Neoplasms Cancer Pain Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms |
Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pain Neurologic Manifestations |