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

NCT ID: NCT01347723

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-12-31

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

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.

Conditions

Pain; Peripheral Neuropathy

Study Groups

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.

scrambler therapy

Intervention Type: OTHER

Undergo scrambler therapy

questionnaire administration

Intervention Type: OTHER

Ancillary studies

management of therapy complications

Intervention Type: PROCEDURE

Undergo scrambler therapy

Interventions

scrambler therapy

Undergo scrambler therapy

Intervention Type: OTHER

questionnaire administration

Ancillary studies

Intervention Type: OTHER

management of therapy complications

Undergo scrambler therapy

Intervention Type: PROCEDURE

Other Intervention Names

complications of therapy, management of

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Loprinzi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

NCI-2011-00339

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC10CC

Identifier Type: OTHER

Identifier Source: secondary_id

11-000675

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00339

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC10CC

Identifier Type: -

Identifier Source: org_study_id