Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01347723

Collaborator

(none)

194

Enrollment

Location

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pain Peripheral Neuropathy	Other: scrambler therapy Other: questionnaire administration Procedure: management of therapy complications

Detailed Description

OBJECTIVES:

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

To explore neurologic testing changes in patients receiving scrambler therapy.

Study Design

Study Type:

Observational

Actual Enrollment :

194 participants

Official Title:

Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: complications of therapy, management of

Arm

Intervention/Treatment

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 Names:

complications of therapy, management of

Outcome Measures

Primary Outcome Measures

Change in pain on a 0-10 numerical rating scale. [3 years]

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. [3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Charles Loprinzi, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01347723

Other Study ID Numbers:

MC10CC
NCI-2011-00339
MC10CC
11-000675
NCI-2011-00339

First Posted:

May 4, 2011

Last Update Posted:

May 14, 2020

Last Verified:

Jan 1, 2016

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Study Results

No Results Posted as of May 14, 2020