NCT03707444

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

October 11, 2018

Last Update Submit

November 26, 2019

Conditions

Cancer PancreasPain SyndromeCancer Related Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Average pain as assessed by Brief Pain Inventory Question 3

    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.

    Day 0, Day 28

Secondary Outcomes (2)

  • Change in Pain as assessed by Brief Pain Inventory

    Day 0, Day 28

  • Change in opioid use

    Day 0, Day 28

Study Arms (1)

Scrambler Therapy

All participants get the same device treatment with the Scrambler Therapy device, up to 10 treatments.

Device: Scrambler Therapy Device

Interventions

Scrambler Therapy DeviceDEVICE

Superficial neuromodulation using EKG type electrodes \[Scrambler (MC5-A Calmare) Therapy\]

Scrambler Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients over age 18 with pancreas cancer and cancer related pain

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (12)

  • Raucci U, Tomasello C, Marri M, Salzano M, Gasparini A, Conicella E. Scrambler Therapy((R)) MC-5A for Complex Regional Pain Syndrome: Case Reports. Pain Pract. 2016 Sep;16(7):E103-9. doi: 10.1111/papr.12474. Epub 2016 Jul 2.

    PMID: 27370908BACKGROUND

  • Starkweather AR, Coyne P, Lyon DE, Elswick RK Jr, An K, Sturgill J. Decreased low back pain intensity and differential gene expression following Calmare(R): results from a double-blinded randomized sham-controlled study. Res Nurs Health. 2015 Feb;38(1):29-38. doi: 10.1002/nur.21632. Epub 2015 Jan 8.

    PMID: 25572279BACKGROUND

  • Marineo G. Untreatable pain resulting from abdominal cancer: new hope from biophysics? JOP. 2003 Jan;4(1):1-10.

    PMID: 12555009RESULT

  • Majithia N, Smith TJ, Coyne PJ, Abdi S, Pachman DR, Lachance D, Shelerud R, Cheville A, Basford JR, Farley D, O'Neill C, Ruddy KJ, Sparadeo F, Beutler A, Loprinzi CL. Scrambler Therapy for the management of chronic pain. Support Care Cancer. 2016 Jun;24(6):2807-14. doi: 10.1007/s00520-016-3177-3. Epub 2016 Apr 4.

    PMID: 27041741RESULT

  • Smith TJ, Coyne PJ, Parker GL, Dodson P, Ramakrishnan V. Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare(R)) for chemotherapy-induced peripheral neuropathy. J Pain Symptom Manage. 2010 Dec;40(6):883-91. doi: 10.1016/j.jpainsymman.2010.03.022.

    PMID: 20813492RESULT

  • Marineo G, Iorno V, Gandini C, Moschini V, Smith TJ. Scrambler therapy may relieve chronic neuropathic pain more effectively than guideline-based drug management: results of a pilot, randomized, controlled trial. J Pain Symptom Manage. 2012 Jan;43(1):87-95. doi: 10.1016/j.jpainsymman.2011.03.015. Epub 2011 Jul 16.

    PMID: 21763099RESULT

  • Ricci M, Pirotti S, Scarpi E, Burgio M, Maltoni M, Sansoni E, Amadori D. Managing chronic pain: results from an open-label study using MC5-A Calmare(R) device. Support Care Cancer. 2012 Feb;20(2):405-12. doi: 10.1007/s00520-011-1128-6. Epub 2011 Mar 11.

    PMID: 21394458RESULT

  • Sabato AF, Marineo G, Gatti A. Scrambler therapy. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):479-82.

    PMID: 16012423RESULT

  • Russo D, Zoratto F, Tirocchi G, Guarda M. Scrambler therapy in the management of somatosensory signs and symptoms related to neuropathic pain: an exploratory and prospective analysis. Acta Biomed. 2018 Jun 7;89(2):180-185. doi: 10.23750/abm.v89i2.5704.

    PMID: 29957749RESULT

  • Smith T, Cheville AL, Loprinzi CL, Longo-Schoberlein D. Scrambler Therapy for the Treatment of Chronic Post-Mastectomy Pain (cPMP). Cureus. 2017 Jun 21;9(6):e1378. doi: 10.7759/cureus.1378.

    PMID: 28775918RESULT

  • Kashyap K, Joshi S, Vig S, Singh V, Bhatnagar S. Impact of Scrambler Therapy on Pain Management and Quality of Life in Cancer Patients: A Study of Twenty Cases. Indian J Palliat Care. 2017 Jan-Mar;23(1):18-23. doi: 10.4103/0973-1075.197948.

    PMID: 28216858RESULT

  • Compagnone C, Tagliaferri F; Scrambler Therapy Group. Chronic pain treatment and scrambler therapy: a multicenter retrospective analysis. Acta Biomed. 2015 Sep 14;86(2):149-56.

    PMID: 26422429RESULT

MeSH Terms

Conditions

Pancreatic NeoplasmsSomatoform DisordersCancer Pain

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas J Smith, MD

    Johns Hopkins Sidney Kimmel COmprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 16, 2018

Study Start

October 1, 2018

Primary Completion

October 31, 2019

Study Completion

November 26, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)