Pain Syndrome Clinical Trial
Official title:
A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer
Verified date | November 2019 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 26, 2019 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Ho-Chiang Foundation |
United States,
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. — View Citation
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. Erratum in: In — View Citation
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 — View Citation
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):87-9 — View Citation
Marineo G. Untreatable pain resulting from abdominal cancer: new hope from biophysics? JOP. 2003 Jan;4(1):1-10. — View Citation
Raucci U, Tomasello C, Marri M, Salzano M, Gasparini A, Conicella E. Scrambler Therapy(®) 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. — View Citation
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® device. Support Care Cancer. 2012 Feb;20(2):405-12. doi: 10.1007/s00520-011-1128-6. Epub 2011 Mar 11. Err — View Citation
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. — View Citation
Sabato AF, Marineo G, Gatti A. Scrambler therapy. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):479-82. — View Citation
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. — View Citation
Smith TJ, Coyne PJ, Parker GL, Dodson P, Ramakrishnan V. Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare®) for chemotherapy-induced peripheral neuropathy. J Pain Symptom Manage. 2010 Dec;40(6):883-91. doi: 10.1016/j.jp — View Citation
Starkweather AR, Coyne P, Lyon DE, Elswick RK Jr, An K, Sturgill J. Decreased low back pain intensity and differential gene expression following Calmare®: 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in Pain as assessed by Brief Pain Inventory | 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. | Day 0, Day 28 | |
Secondary | Change in opioid use | 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. | Day 0, Day 28 |
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