Clinical trial · Interventional
Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
NCT05357469CI-TRIAL-00117180active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of Scrambler therapy (ST) for chemotherapy-induced painful peripheral neuropathy (CIPN), and the impact of ST on physical functioning and quality of life (QoL) in adolescents and young adults (AYA) cancer patients. In this proposed study, we will conduct a two-arm prospective, randomized wait-list controlled clinical trial to investigate the effectiveness of ST on pain and CIPN in AYAs with cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immediate St (Scrambler Therapy) | Device | — | UNRESOLVED |
| Waitlist ST (Scrambler Therapy) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate St (Scrambler Therapy)
- description
- Participant will start ST (Scrambler Therapy) treatment right away.
- interventionNames
- Device: Immediate St (Scrambler Therapy)
- type
- EXPERIMENTAL
- label
- Waitlist ST (Scrambler Therapy)
- description
- Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.
- interventionNames
- Device: Waitlist ST (Scrambler Therapy)
Primary outcomes (1)
- measure
- The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. \- Both genders aged 15-39 years 2. \- Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy. 3. \- Patients have had cancer and are not being actively treated, 4. \- Patients who speaks English and able to complete questionnaires by themselves or with help from parents and/or nurses. Written informed consent will be obtained from adults (aged 18-39 years) or from parents/guardians of adolescents (aged 15-17 years) and assent will be obtained from adolescents (aged 15-17 years) under an Institutional Review Board (IRB)-approved protocol. Exclusion Criteria: 1. \- Inability to walk or stand without assistance (need for ambulatory-assist devices) 2. \- Bone and/or central nervous system metastases that affect gait, walking and balance 3. \- History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions. 4. \- Implanted intrathecal drug-delivery system or a spinal cord and/or peripheral nerve stimulator; a) a metal implant such as a cardiac pacemaker, automatic defibrillator, aneurysm clips, vena cava clips, or skull plate. 5. \- History of epilepsy. 6. \- Skin damage at the site of electrode placement; and i) prior ST treatment; j) Patients on pain medications for other than CIPN.
References
Publications (0)
Data not yet available
No reference posted for this study.