Brief Summary

This trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. Scrambler therapy is a type of treatment that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

April 4, 2019

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed

Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

January 21, 2020

Last Update Submit

March 22, 2022

Conditions

Chemotherapy-Induced Peripheral Neuropathy Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

Chemotherapy induced peripheral neuropathic pain (CIPN) score difference
Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
Baseline to the last day of 2-week treatment

Secondary Outcomes (3)

Change in therapy-induced neuropathy
Baseline to the last day of 2-week treatment
Change in cancer-related symptoms
Baseline to the last day of 2-week treatment
Change in physical function and quality of life
Baseline to the last day of 2-week treatment

Study Arms (1)

Supportive Care (scrambler therapy, sensory test, gait test)

EXPERIMENTAL

Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.

Device: FitBitOther: Gait Assessment TestOther: MC5-A Scrambler TherapyOther: Quality-of-Life AssessmentProcedure: Quantitative Sensory TestingOther: Questionnaire Administration