Chemotherapy-induced Peripheral Neuropathy study: Scrambler Therapy
Official title Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT07219472
What this study is testing
- What it's testing
- This study aims to see if Scrambler Therapy reduces nerve pain, improves daily activities, and boosts quality of life for people with chemotherapy-induced peripheral neuropathy.
- Who it's for
- People who have nerve pain, numbness, or tingling in their hands or feet caused by cancer treatment.
- What's involved
- Participants will be randomly assigned to receive either Scrambler Therapy or no treatment. The therapy involves wearing a device that sends electrical signals through wires attached to the skin for 10 daily one-hour sessions.
- Time commitment
- The study lasts about 12 to 14 months and includes regular visits to track symptoms and quality of life.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults with CIPN-related pain for at least three months duration, and for which the participant wants intervention
- At least three months from the last dose of neurotoxic cancer-directed drug
- No plan (at the time of study enrollment) for additional neurotoxic cancer-directed therapies for at least five months after trial enrollment
- Pain rated ≥ four out of 10 in severity (0-10 pain scale) during the seven days prior to enrollment
- \> Six-month life expectancy
You likely can't join if
- Pregnant or nursing
- An operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and/or medical monitoring device
- History of myocardial infarction or ischemic heart disease within six months of trial enrollment
- History of epilepsy, brain damage resulting in seizure activity, or use of anticonvulsants for seizure
- Skin conditions such as open sores that will prevent proper application of electrodes
- Unwillingness or inability to wean and discontinue gabapentin or pregabalin prior to the start of ST
See the full eligibility criteria
- Adults with CIPN-related pain for at least three months duration, and for which the participant wants intervention
- At least three months from the last dose of neurotoxic cancer-directed drug
- No plan (at the time of study enrollment) for additional neurotoxic cancer-directed therapies for at least five months after trial enrollment
- Pain rated ≥ four out of 10 in severity (0-10 pain scale) during the seven days prior to enrollment
- \> Six-month life expectancy
- Able to complete questionnaires by themselves or with assistance
- Able to provide informed written consent
- ECOG Performance Status score ≥ two
- Not currently enrolled in another research study for pain or neuropathy
- Pregnant or nursing
- An operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and/or medical monitoring device
- History of myocardial infarction or ischemic heart disease within six months of trial enrollment
- History of epilepsy, brain damage resulting in seizure activity, or use of anticonvulsants for seizure
- Skin conditions such as open sores that will prevent proper application of electrodes
- Unwillingness or inability to wean and discontinue gabapentin or pregabalin prior to the start of ST
- History of symptomatic peripheral neuropathy prior to receiving neurotoxic chemotherapy
- Prior treatment with Scrambler Therapy
- The presence of chronic regional pain syndrome (CRPS) in the scrambler therapy treatment area.
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.