ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03322007
Recruitment Status : Not yet recruiting
First Posted : October 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Y.C. Ho/Helen and Michael Chiang Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Pain, Chronic Device: Scrambler Therapy Not Applicable

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single institution, single arm trial of Scrambler Therapy for Pancreas Cancer Pain
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Open label treatment
Usual FDA-cleared pain management with Scrambler Therapy
 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
Other Name: Calmare Therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Brief Pain Inventory pain at day 28 [ Time Frame: 28 days ]
    usual or average pain that day, Q3 on BPI


Secondary Outcome Measures :
  1. EORTC Quality of Life [ Time Frame: 28 days ]
    QOL standard for pancreas cancer


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322007


Contacts
Contact: Thomas J Smith, MD 410 955 2097 tsmit136@jhmi.edu
Contact: Paula Eissmann, BA 410 955 2097 peissman1@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287-0013
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Y.C. Ho/Helen and Michael Chiang Foundation
Investigators
Principal Investigator: Thomas J Smith, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: https://e-irb.jhmi.edu/eirb2
Please email me a request and I can send the actual protocol.

Publications:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03322007     History of Changes
Other Study ID Numbers: J15120
IRB00063416 ( Other Identifier: JHMIRB )
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
pain
pancreas cancer
Scrambler Therapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Chronic Pain
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pancrelipase
Pancreatin
Gastrointestinal Agents