Abstract
Wireless transcutaneous electric nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy (CIPN): A proof-of-concept, placebo-controlled, randomized clinical trial (RCT)
Journal of clinical oncology, Vol.41(16_suppl), pp.e24134-e24134
06/01/2023
DOI: 10.1200/JCO.2023.41.16_suppl.e24134
Abstract
e24134 Background: Chronic 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. Methods: 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) (NCT 04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were hot/burning pain, sharp/shooting pain, tingling, numbness, and cramping (7-day daily diary, 0 – 10 numeric rating scales). The TENS device applies stimulation for 1hr treatment sessions followed by 1 hour rest periods. The placebo TENS device is identical, except it delivers only 2.5 mins of stimulation in the treatment period. Subjects were asked to wear the device for 5 hrs/day (i.e., 3 treatment sessions) for 6 weeks. The primary analysis used an ANCOVA with the 6-week EORTC-CIPN20 score as the dependent variable, arm as fixed effect, and baseline EORTC-CIPN20 and site as covariates. Secondary analyses used similar ANCOVA models (excluding site) for each symptom on subgroups of subjects who reported at least 4 out 10 for that symptom at baseline. Results: 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. Subjects were on average 63 years old, 65% female, and 85% white. The most common chemotherapies were taxanes (37%), platinums (36%), or their combination (15%). 88% of study completers received at least 3 treatment sessions on at least 70% of study days. The median time since chemotherapy was 16 months (IQR: 7, 34). See Table for efficacy results. Conclusions: A RCT of an app-controlled, wireless TENS device for chronic CIPN with excellent adherence and retention rates is feasible in NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN, but less likely to improve numbness and tingling. A confirmatory RCT of TENS for painful CIPN is highly warranted. Clinical trial information: NCT04367480 . [Table: see text]
Details
- Title: Subtitle
- Wireless transcutaneous electric nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy (CIPN): A proof-of-concept, placebo-controlled, randomized clinical trial (RCT)
- Creators
- Jennifer S. Gewandter - University of Rochester Medical CenterEva Culakova - University of Rochester Medical CenterJenae N Davis - University of Rochester Medical CenterUmang Gada - University of Rochester Medical CenterJoseph John Guido - University of Rochester Medical CenterBrian Leslie Burnette - Michigan Cancer Research ConsortiumJames D. Bearden - University of South Carolina UpstateMark Allen O'Rourke - Prisma HealthKaren Michelle Mustian - University of Rochester Medical CenterGary R. Morrow - University of Rochester Medical CenterKathleen A Sluka - University of IowaNimish Mohile - University of Rochester Medical Center
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.41(16_suppl), pp.e24134-e24134
- DOI
- 10.1200/JCO.2023.41.16_suppl.e24134
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- DOI: 10.13039/100000002, name: U.S. National Institutes of Health; name: Neurometrix provided devices
- Language
- English
- Date published
- 06/01/2023
- Academic Unit
- Nursing; Neuroscience and Pharmacology; Iowa Neuroscience Institute; Physical Therapy and Rehabilitation Science
- Record Identifier
- 9984442226902771
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