Papers of the Week

Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 30%-60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. This 6-site, subject and assessor blinded RCT was designed to assess (1) preliminary efficacy (i.e., alpha pre-specified at 0.2) of a wearable, app-controlled, TENS device for chronic CIPN and (2) feasibility of conducting a confirmatory trial within the NCI Community Oncology Research Program (NCORP) (NCT04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were individual symptoms assessed daily (via 0 – 10 numeric rating scales). The primary analysis was an ANCOVA (outcome: EORTC-CIPN20, fixed effect: arm, covariates: baseline EORTC-CIPN20 and site). Secondary analyses used similar ANCOVA models (excluding site) for each symptom on subgroups of subjects with ≥4 out of 10 for that symptom at baseline. 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. The difference between groups in the EORCT-CIPN20 at endpoint (placebo-active) was 1.05 (95% CI: -0.56, 2.67; p = 0.199). The difference between groups for the individual symptoms were as follows: hot/burning pain: 1.37 (-0.33, 3.08; p=0.112), sharp/shooting pain: 1.21 (-0.37, 2.79; p=0.128), cramping: 1.35 (-0.32, 3.02; p=0.110), tingling: 0.23 (-0.61, 1.08; p=0.587), numbness: 0.27 (-0.51, 1.05; p=0.492). A RCT of an app-controlled TENS device for chronic CIPN with excellent retention is feasible in NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN. A confirmatory RCT of TENS for painful CIPN is highly warranted. PERSPECTIVE: Daily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial. Future confirmatory trial is warranted.