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Home-Based Exercise and Vagus Nerve Stimulation for Chemotherapy-Induced Neuropathy
Sponsor: The Hong Kong Polytechnic University
Summary
Background: Studies highlight the potential benefits of home-based exercise for cancer survivors with chemotherapy-induced neuropathy (CIN); however, its effectiveness in alleviating CIN-related sensorimotor impairments and symptoms has been inconsistent and generally modest. Non-invasive vagus nerve stimulation (nVNS) has emerged as a promising adjunct for CIN rehabilitation. Preliminary studies suggest that nVNS can enhance the therapeutic effects of exercise-based rehabilitation, leading to greater improvements in sensorimotor impairments. A recent trial found that nVNS alleviated CIN-related pain and improved mental well-being, but did not significantly enhance physical well-being or clinician-rated CIN severity. Objectives: To evaluate the efficacy, safety, and feasibility of combining home-based exercise with non-invasive vagus nerve stimulation (nVNS) to alleviate chemotherapy-induced neuropathy (CIN) and improve quality of life in cancer survivors. Design and Subjects: This phase II randomized controlled trial will enroll 60 cancer survivors with established CIN following treatment with platinum compounds or taxanes. Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: exercise with real nVNS (ERS), exercise with sham nVNS (ESS), or usual care. Interventions: Participants in the experimental groups will engage in a 12-week home-based exercise program, with the ERS group receiving real nVNS and the ESS group receiving sham stimulation. Study Instruments and Main Outcome Measures: The primary outcome, patient-reported CIN, will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item (EORTC QLQ-CIPN20). Secondary outcomes will include the Total Neuropathy Score-nurse for clinician-reported CIN, the Symptom Distress Scale for general symptoms, functional performance measures (Timed Up and Go Test and 6-Minute Walk Test), and the EORTC QLQ-Core 30-item for quality of life. Data Analysis and Expected Results: Generalized Estimating Equations will be used for efficacy outcome analysis. It is anticipated that the combined intervention may lead to improvements in CIN, functioning, and quality of life, thereby supporting further research in larger trials.
Official title: Combining Home-Based Exercise and Non-Invasive Vagus Nerve Stimulation to Enhance Rehabilitation for Cancer Survivors With Chemotherapy-Induced Neuropathy: A Phase II Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-12-21
Completion Date
2028-12-20
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Active non-invasive vagus nerve stimulation (nVNS)
nVNS will be applied to the left auricular region during the 12-week home-based exercise program. The ERS group will receive real stimulation at a frequency of 25 Hz, a pulse width of 250 µs, a pulse-train duration of 30 seconds on and 30 seconds off, and an intensity set at the maximum tolerable level for each participant (0.25-2.0 mA). Stimulation will be stopped during rest and after exercise. A portable device (tVNS501; Changzhou Rishena Medical Device Co., Ltd., Jiangsu, China) will be used to deliver the stimulation. During the first face-to-face training session, a trained research associate will configure the device parameters and position the electrode on the participant's left cymba concha. Subsequently, participants will be trained to self-administer the stimulation during home-based exercise.
Sham non-invasive vagus nerve stimulation (nVNS)
The ESS group will undergo sham stimulation using the same device and electrode placement as the ERS group. Sham stimulation will be administered by the same trained research associate during the first face-to-face training session and subsequently self-administered by the participants during the 12-week home-based exercise program. However, the stimulator will be set to deliver a low stimulation frequency of 1 Hz at an intensity that elicits only the minimum perceptible sensation, with the aim of inducing a subtherapeutic placebo effect by mimicking active stimulation. The pulse width will be set to the lowest output of the stimulator, 100 µs, and the pulse-train duration will be 10 seconds on and 50 seconds off, thereby minimizing any potential physiological effects.
Home-based aerobic and resistance exercise program
The home-based exercise program includes aerobic and resistance training at moderate intensity (modified Borg 3-5/10). Aerobic: daily walking 30 min, initial step goal based on pre-intervention average daily steps, increased by 5-20% each week for 12 weeks, with self-monitoring of Borg and weekly follow-up guidance. Resistance: upper- and lower-body elastic band exercises (shoulder flexion/extension, horizontal abduction, elbow flexion/extension, heel raises, partial squats), 1-2 sets of 6 repetitions per set, completed within 1 minute, with 1-1.5 minutes of rest between sets, for a total of up to 30 minutes, progressing to a maximum of 15 repetitions per set. Participants receive an instruction booklet, three elastic bands, and a wrist pedometer. A 60-min face-to-face training session is delivered by a trained research associate at a study hospital, a university teaching room, or the participant's home.
Locations (3)
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong, Hong Kong
Department of Surgery, Kwong Wah Hospital
Hong Kong, Hong Kong