The US FDA Amendments Act (FDAAA 2007) requires certain clinical trials to report their results onto ClinicalTrials.gov within one year of completion. Our FDAAA TrialsTracker shows all individual trials that breach this legal requirement. Once a week, we write about one unreported clinical trial: you can read more background here.

Trial NCT02111174

This week’s unreported trial is titled: “A Pilot Randomized Sham-Controlled Trial of MC5-A Calmare Therapy (Scrambler Therapy) in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)” (NCT02111174). The trial enrolled 30 adult participants experiencing CIPN pain. The intervention group received treatment with a scrambler therapy device; the control group received a sham version of the treatment. The study was blinded for participants, care providers, and outcome assessors. The primary outcome was change in pain at 28 days as measured by Modified Brief Pain Index score. The secondary outcomes were changes in pain measured by the Brief Pain Inventory, changes in patient reported outcomes and changes in pain drug use.

Clinical Discussion

Peripheral neuropathy occurs when “nerves in the body’s extremities—such as the hands, feet and arms—are damaged” which can cause pain and discomfort. While this is a common condition in the elderly, it can also occur as a side effect of chemotherapy. A 2014 systematic review found that the prevalence of CIPN was 68.1% in the first month following chemotherapy. If CIPN in severe enough, it could interfere with the patient’s chemotherapy regimen as well as have major impacts on patient quality of life. Scrambler therapy, in which electrodes are placed onto affected areas and deliver “electrical stimulation of pain fibers with the intent of re-organizing maladaptive signaling pathways” may be a way to treat CIPN. A 2016 review found largely positive findings on the effectiveness of scrambler therapy in CIPN. Additional trials and case studies, including some by the PI of this study, continue to be published showing the promise of this device in the treatment of peripheral neuropathy and other forms of pain. As experts demand more progress in the treatment of CIPN, it is important that this study be reported to add to this growing evidence base for this promising new therapy option.

Legislative Discussion

We intend that this series should occasionally shed light on interesting issues around transparency rules, and how registry data is used. You can read some general background about the FDA Amendments Act 2007—and why a trial is considered “due”—here and here.

Last week’s Unreported Clinical Trial of the Week covered the first non-drug treatment of the series. This week we present the first unreported trial on a medical device. Medical devices are important treatment options for millions of people. Some registries, such as the EUCTR, do not cover trials of medical devices; however the FDAAA 2007 requires applicable device trials to register and report results onto ClinicalTrials.gov.