Grant Number:	1R01CA298345-01A1 Interpret this number
Primary Investigator:	Winters-Stone, Kerri
Organization:	Oregon Health & Science University
Project Title:	LIVE: Efficacy of Low Intensity Vibration Therapy to Reduce Symptoms of Peripheral Neuropathy and Preserve Functional Mobility After Chemotherapy for Cancer
Fiscal Year:	2026

Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating cancer treatment-related toxicity that can markedly impact patients' quality of life (QOL), physical functioning, mobility, independence, and fall risk. CIPN occurs in close to 90% of patients while receiving neurotoxic chemotherapy and persists for months to years after treatment ends in upwards of 50% of patients. Despite CIPN's threats to patient outcomes and long-term health, there are currently no therapies with sufficient evidence to treat both CIPN symptoms (i.e., numbness, tingling, and pain) and associated functional impairments (i.e., impaired proprioception, postural instability, altered gait). Low-intensity vibration (LIV) training is an innovative, non-invasive treatment modality in which oscillating mechanical signals are passively delivered to a person standing on a vibrating platform, mimicking key exercise physiologic parameters. LIV delivered from a device with an oscillating platform to the standing participant uses extremely small (0.4g), high-frequency (30Hz) mechanical signals and has established safety across multiple patient cohorts but has not been rigorously tested in cancer survivors suffering from CIPN. LIV can be delivered at home without clinical supervision and is barely perceptible: if a participant can stand for 10- minute periods, they can receive the intervention. LIV may be a novel, home-based, and drug-free therapeutic CIPN intervention because it inhibits central and peripheral pain pathways while improving function. Results from our pilot study in a small sample of cancer survivors with persistent CIPN symptoms (n=38) suggest that a small LIV dose (10 minutes twice daily for 12 weeks) is feasible, safe, reduces numbness/tingling, and improves perceived functioning and postural stability. These findings require a larger, fully-powered trial that includes a blinded-placebo group, objective measures of sensory function, and a follow-up period to establish LIV's durability of benefits. We propose a double-blind, placebo-controlled, phase III randomized controlled trial that tests the hypothesis that LIV (two 10-minute sessions/day, 7 days/week, for 12 weeks) compared to placebo will reduce persistent CIPN symptoms while improving stability, physical functioning, and mobility in 270 people previously treated with platinum- and/or taxane-based chemotherapy who have persistent (≥6 months) CIPN sensory symptoms. We further hypothesize that people randomized to LIV will have lower CIPN symptoms and better functioning than people in the placebo group at 12 weeks post-intervention. We will also identify characteristics of patients who may benefit more from LIV to inform future studies and clinical practice. Our study will address the following Specific Aims: (1) Determine whether and for how long LIV reduces CIPN symptoms compared to placebo control, (2) Determine whether and for how long LIV improves physical functioning (patient- reported, measured stability and mobility) compared to placebo control and (3) Identify the characteristics of patients with clinical improvement in symptoms and function from LIV. The overarching goal of our trial directly aligns with the Cancer Moonshot goal to improve the lives of people living with and surviving cancer.





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