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NCT02111174 · ClinicalTrials.gov registry record · NA
Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
NCT02111174: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02111174 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02111174, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will relieve chemotherapy induced peripheral neuropathy (CIPN). Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy machine directs electrical signals across the field to simulate non-pain information. Based on other studies, we think that we relieve pain with the Scrambler therapy device, but it has not been tested in a setting such as this one. This means that some of the pain relief could be due to placebo effect, or the CIPN pain going away on its own. In this study we want to compare the Scrambler Therapy with the sham therapy (the therapy that does not use the electrical signals). We hope that this study will help us determine if the Scrambler device really helps patients with CIPN. Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for at least 3 months may be eligible to join this study.
Primary Outcome
To determine the change in pain from day 0 to day 28 (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.
Interventions
- DEVICE Scrambler Therapy
- DEVICE Sham Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-03-24 |
| Phase | NA |
What the finished NCT02111174 record still lists
NCT02111174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Scrambler Therapy is the first listed.
NCT02111174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02111174 about?
NCT02111174 is a clinical study titled "Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy". The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will relieve chemotherapy induced peripheral neuropathy (CIPN). Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin electrodes. The electrodes are placed on the body in ...
What is the current status of trial NCT02111174?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2015-03. Estimated completion is 2017-03-24.
What interventions are being tested in trial NCT02111174?
The interventions under investigation include: Scrambler Therapy (DEVICE), Sham Therapy (DEVICE).
Who is sponsoring clinical trial NCT02111174?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02111174's enrollment target sits among peer trials
37 1540th of 2000 higher than 460 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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