Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy - Full Text View

Purpose

This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy

Condition	Intervention
Pain Peripheral Neuropathy	Other: scrambler therapy Other: questionnaire administration Procedure: management of therapy complications


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Nerve Disorders

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Patients will also undergo neurologic function testing. This will be done in an exploratory measure to try to correlate changes in the patient reported outcome instrument data with changes in the different measures of neurologic function. The two measures will be Neurometer Current Perception Threshold (CPT) Testing and testing with a Rydel-Seiffer graduated tuning fork.


Enrollment:	194
Study Start Date:	March 2011
Study Completion Date:	December 2015
Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Supportive care (pain therapy) Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity.	Other: scrambler therapy Undergo scrambler therapy Other: questionnaire administration Ancillary studies Procedure: management of therapy complications Undergo scrambler therapy Other Name: complications of therapy, management of

Detailed Description:

OBJECTIVES:

I. To record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy.

II. To get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use.

OUTLINE: Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 10 weeks.

III. To explore neurologic testing changes in patients receiving scrambler therapy.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pain or symptoms of neuropathy or pain of >= 1 month (30 days) duration for which the patient wants intervention
Participants have to relate that tingling or pain was at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem and expected to have tingling or pain of at least 4/10 at the time of the first treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
Life expectancy >= 3 months (90 days)
Case review by the study chair, or designate, as a case where treatment should be tried.
Ability to complete questionnaire(s) by themselves or with assistance - Ability to provide informed written consent

Exclusion Criteria:

Pregnant women
Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices)
Patients with a history of myocardial infarction or ischemic heart disease within the past six months
Patients with history of epilepsy, brain damage, use of anti-convulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
Skin conditions such as open sores that would prevent proper application of the electrodes
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Currently on gabapentin or pregabalin Note: (because of data that support that patients don't do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off of them prior to study initiation. The study team will provide instructions on how to do this).

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347723

Locations


United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators


Principal Investigator:	Charles Loprinzi	Mayo Clinic

More Information


Responsible Party:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01347723 History of Changes
Other Study ID Numbers:	MC10CC NCI-2011-00339 MC10CC 11-000675 NCI-2011-00339
Study First Received:	March 30, 2011
Last Updated:	January 6, 2016
Health Authority:	United States: Federal Government United States: Institutional Review Board

Additional relevant MeSH terms:


Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016