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A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT03707444
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Ho-Chiang Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:
Pain is the predominant and most feared symptom of pancreas cancer, and is often incompletely relieved. Scrambler Therapy is a new way of treating pain by providing "non-pain" information to confuse the nervous system and reset the damaged nerve pathways. It has been useful in treating many types of pain, but has not been adequately tested in the pain associated with pancreas cancer. The goal of this study is to evaluate the effect of Scrambler Therapy on typical abdominal pain associated with pancreas cancer. The investigators hypothesize that pain scores from day 0 (pre) to day 28 (post) will be reduced by at least 33%, e.g. from 6/10 to 4/10.

Condition or disease Intervention/treatment Phase
Cancer Pancreas Pain Syndrome Cancer Related Pain Device: Scrambler Therapy Device Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm study of 20 patients
Masking: None (Open Label)
Primary Purpose: Treatment
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 : October 31, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Scrambler Therapy
All participants get the same device treatment with the Scrambler Therapy device, up to 10 treatments.
 Device: Scrambler Therapy Device
Superficial neuromodulation using EKG type electrodes [Scrambler (MC5-A Calmare) Therapy]


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • 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

  • 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.
Contacts and Locations
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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): NCT03707444


Contacts
Contact: Thomas J Smith, MD 410-955-2091 tsmit136@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Thomas J Smith, MD    410-955-2091    tsmit136@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Ho-Chiang Foundation
Investigators
Principal Investigator: Thomas J Smith, MD Johns Hopkins Sidney Kimmel COmprehensive Cancer Center
More Information
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Publications of Results:

Other Publications:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03707444     History of Changes
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: October 24, 2018
Last Verified: October 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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
Nervous System Diseases
Signs and Symptoms
Pancrelipase
Gastrointestinal Agents