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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347723
• Other study ID #: MC10CC
• Secondary ID: NCI-2011-00339MC
• Status: Completed
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Other:
• scrambler therapy
Undergo scrambler therapy
• questionnaire administration
Ancillary studies

Procedure:
• management of therapy complications
Undergo scrambler therapy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain on a 0-10 numerical rating scale.		3 years
Secondary	Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork.	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.	3 years