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

NCT01347723 | Completed DMC

• 3 other identifiers: MC10CCNCI-2011-0033911-000675
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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

Conditions

Pain; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in pain on a 0-10 numerical rating scale.

  3 years

Secondary Outcomes (1)

• Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork.

  3 years

Study Arms (1)

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; Other: questionnaire administration; Procedure: management of therapy complications

Interventions

scrambler therapy OTHER

Undergo scrambler therapy

Supportive care (pain therapy)

questionnaire administration OTHER

Ancillary studies

Supportive care (pain therapy)

management of therapy complications PROCEDURE

Undergo scrambler therapy

Also known as: complications of therapy, management of

Supportive care (pain therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Charles Loprinzi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: May 4, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 14, 2020

Record last verified: 2016-01

Locations

US (1)