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

Specific aims include the following:

1. To determine the change in pain from day 0 to day 28 with scrambler therapy in patients
with pancreas cancer pain. (Question #3 of the Modified Brief Pain Inventory). This
endpoint serves to get preliminary information on the effect size for planning future
larger, phase III studies comparing to splanchnic or celiac nerve blocks. The primary
measurement tool for pain will be the Brief Pain Inventory (BPI).

2. To determine changes in the complete Brief Pain Inventory; changes in pain drug use; and
changes in quality of life (QOL) using the EORTC QUALITY OF LIFE QUESTIONNAIRE-PANCREAS
26, our current Hopkins standard. With 18 patients and a one-sided type 1 error rate of
10%, we have 87% power to detect a 33% reduction in pain, the primary endpoint, and can
complete this in one year. To ensure completion, we will enroll 20.

Inclusion Criteria:

Inclusion Criteria will be 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 following question from the BPI:
"Please rate your pain by circling the one number that best describes your (abdominal)
pain/discomfort on average over the past week. (Scale 0-10; 0= No pain, 10= Pain as bad as
you can imagine)". They must have a life expectancy > 5 days, so that some treatments can
be given), and ECOG Performance Status 0, 1, 2, 3, or 4

- 0 Normal activity. Fully active, able to carry on all pre-disease performance without
restriction.

- 1 Symptoms, but ambulatory. Restricted in physically strenuous activity, but
ambulatory and able to carry out work of a light or sedentary nature (e.g., light
housework, office work).

- 2 In bed < 50% of the time. Ambulatory and capable of all self-care, but unable to
carry out any work activities. Up and about more than 50% of waking hours.

- 3 In bed > 50% of the time. Capable of only limited self-care, confined to bed or
chair more than 50% of waking hours.

- 4 100% bedridden. Completely disabled. Cannot carry on any self-care. Totally confined
to bed or chair.

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:

- Exclusion Criteria include any of the following: 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.). Other exclusions include the following:

- 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).

- Medical exclusions include: patients with 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
medical 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 (Moon 2014). The study team will provide instructions on how to do this.