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

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.

Sex

All

Minimum age

18 Years

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.

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