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

This study is currently recruiting participants.
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01347723
First received: March 30, 2011
Last updated: March 13, 2014
Last verified: March 2014

March 30, 2011
March 13, 2014
March 2011
September 2014   (final data collection date for primary outcome measure)
Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01347723 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial

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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Pain
  • Peripheral Neuropathy
  • 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
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.
Interventions:
  • Other: scrambler therapy
  • Other: questionnaire administration
  • Procedure: management of therapy complications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
September 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Not Provided
United States
 
NCT01347723
MC10CC, NCI-2011-00339, MC10CC, 11-000675, NCI-2011-00339
Yes
Loprinzi, Charles, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Charles Loprinzi Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP