Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
Other: scrambler therapy
Other: questionnaire administration
Procedure: management of therapy complications
|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|
- Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- 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.
|Study Start Date:||March 2011|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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 therapyOther: questionnaire administration
Ancillary studiesProcedure: management of therapy complications
Undergo scrambler therapy
Other Name: complications of therapy, management of
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347723
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Mayo Clinic Clinical Trials Office 855-776-0015|
|Principal Investigator: Charles L. Loprinzi|
|Principal Investigator:||Charles Loprinzi||Mayo Clinic|