Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01347723
First received: March 30, 2011
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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 Intervention
Pain
Peripheral Neuropathy
Other: scrambler therapy
Other: questionnaire administration
Procedure: management of therapy complications

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347723

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office    855-776-0015      
Principal Investigator: Charles L. Loprinzi         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Charles Loprinzi Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01347723     History of Changes
Other Study ID Numbers: MC10CC, NCI-2011-00339, MC10CC, 11-000675, NCI-2011-00339
Study First Received: March 30, 2011
Last Updated: September 12, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on November 25, 2014