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

• ClinicalTrials.gov Identifier: NCT01347723
• Recruitment Status: Completed
• First Posted: May 4, 2011
• Last Update Posted: January 8, 2016
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Mayo Clinic

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	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 194 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial
• Study Start Date: March 2011
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 ]
   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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); MC10CC ( Other Identifier: Mayo Clinic Cancer Center ); 11-000675 ( Other Identifier: Mayo Clinic IRB ); NCI-2011-00339 ( Registry Identifier: NCI CTRP )
• First Posted: May 4, 2011
• Last Update Posted: January 8, 2016
• Last Verified: January 2016

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases