NCT03707444|WithdrawnFDA Device
Study Stopped
The PI is dealing with recurrent cancer and multiple side effects of treatment. N o one else to do the study.
Loading search results
Sponsor study identifier
Secondary identifiers
OTHER · Johns Hopkins IRB
observational
0
1 country
1
Study Start
October 1, 2018
Actual (reported)Primary Completion
October 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 26, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 26, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2018
Actual (reported)October 11, 2018
Actual (reported)October 16, 2018
Actual (reported)October 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 26, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Change in Pain as assessed by Brief Pain Inventory
Day 0, Day 28
Change in opioid use
Day 0, Day 28
All participants get the same device treatment with the Scrambler Therapy device, up to 10 treatments.
Superficial neuromodulation using EKG type electrodes \[Scrambler (MC5-A Calmare) Therapy\]
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients over age 18 with pancreas cancer and cancer related pain
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
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.
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.
Thomas J Smith, MD
Johns Hopkins Sidney Kimmel COmprehensive Cancer Center
0 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2018
First Posted
October 16, 2018
Study Start
October 1, 2018
Actual (reported)Virtual Reality for Cancer Pain Management
PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain
Contact the study team to confirm eligibility.
Marineo G. Untreatable pain resulting from abdominal cancer: new hope from biophysics? JOP. 2003 Jan;4(1):1-10.
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.
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.
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.
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.
Sabato AF, Marineo G, Gatti A. Scrambler therapy. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):479-82.
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.
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.
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.
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.
Primary Completion
October 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 26, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 29, 2019
Record last verified: 2019-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: