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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03322007
• Other study ID #: J15120
• Secondary ID: IRB00063416
• Status: Not yet recruiting
• Phase: N/A
• First received: October 23, 2017
• Last updated: October 23, 2017
• Start date: January 1, 2018
• Est. completion date: September 2019

Study information

• Verified date: October 2017
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: Thomas J Smith, MD
• Phone: 410 955 2097
• Email: tsmit136[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BACKGROUND: 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.

OBJECTIVE: The goal of this study is to evaluate the effect of Scrambler Therapy on typical abdominal pain associated with pancreas cancer.

HYPOTHESIS: We 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.

METHODS: 20 patients, with expected data from 18 due to drop out of 2, will be treated with Scrambler Therapy using the standard methods of 45 minute sessions for 10 treatments.

OUTCOMES: We will record data using the Brief Pain Inventory, and EORTC Quality of Life Questionnaire-Pancreas 26 to see if we obtain at least a 33% reduction in pain. This will inform future randomized trials of Scrambler Therapy versus traditional methods such a celiac plexus blocks.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pancreatic Neoplasms

Intervention

Device:
• Scrambler Therapy
external neuromodulation to relieve pain; the device was cleared by the FDA in 2009 for safety, considering it like a TENS unit

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	Y.C. Ho/Helen and Michael Chiang Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

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

Notaro P, Dell'Agnola CA, Dell'Agnola AJ, Amatu A, Bencardino KB, Siena S. Pilot evaluation of scrambler therapy for pain induced by bone and visceral metastases and refractory to standard therapies. Support Care Cancer. 2016 Apr;24(4):1649-54. doi: 10.1007/s00520-015-2952-x. Epub 2015 Sep 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory pain at day 28	usual or average pain that day, Q3 on BPI	28 days
Secondary	EORTC Quality of Life	QOL standard for pancreas cancer	28 days