TENS and Compression for Established Oxaliplatin-Induced Peripheral Neuropathy

Chemotherapy-induced peripheral neuropathy is a clinically important adverse effect of oxaliplatin-based chemotherapy that may cause sensory symptoms, neuropathic pain, functional limitations, and reduced quality of life. This randomized, open-label, four-arm parallel-group study evaluated the comparative effects of transcutaneous electrical nerve stimulation (TENS), compression, sequential TENS followed by compression, and usual care in 140 adults with metastatic gastrointestinal cancer who developed Grade 2 or higher chemotherapy-induced peripheral neuropathy after the first cycle of oxaliplatin-based chemotherapy. Participants were allocated in a 1:1:1:1 ratio. The primary outcome was the EORTC QLQ-CIPN20 total score evaluated longitudinally across the post-baseline treatment-period assessments before Cycles 3-6, with the score obtained before Cycle 2 included as the baseline covariate. The overall Group×Time interaction represented the primary treatment effect, and the baseline-adjusted between-group comparison before Cycle 6 represented the primary endpoint comparison. Secondary outcomes included the EORTC QLQ-CIPN20 sensory, motor, and autonomic domain scores; EORTC QLQ-C30 scale scores; DN4 total score and DN4-defined neuropathic pain positivity; and clinician-rated NCI-CTCAE v5.0 peripheral sensory neuropathy grade. A separate exploratory follow-up assessment was conducted 6 months after Cycle 6.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Aged 18 years or older
* Diagnosed with metastatic gastrointestinal cancer, including gastric, pancreatic, colon, or rectal cancer
* Scheduled to receive six cycles of oxaliplatin-based chemotherapy with FOLFOX or FOLFIRINOX
* Having received one cycle of oxaliplatin-based chemotherapy
* Having Grade 2 or higher chemotherapy-induced peripheral neuropathy according to NCI-CTCAE v5.0 before the Cycle 2 intervention
* Eastern Cooperative Oncology Group performance status of 0-2
* Having provided written informed consent to participate

Exclusion Criteria:

* Having a diagnosed psychiatric disorder that could interfere with informed consent, communication, or adherence to the study procedures
* Having a cardiac pacemaker or another implanted electronic device contraindicating TENS
* Having pre-existing peripheral neuropathy before the initiation of oxaliplatin-based chemotherapy or neuropathy attributable to another cause
* Having diabetes mellitus
* Having peripheral vascular disease or another clinically significant circulatory disorder affecting the hands or feet
* Having a skin lesion or other skin condition at the sites where TENS electrodes or compression garments would be applied