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Home-Based Exercise and Vagus Nerve Stimulation for Chemotherapy-Induced Neuropathy (CIN)
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
- Sponsor
- The Hong Kong Polytechnic University (Academic or other)
- Enrollment
- 60 planned
- Conditions
- Chemotherapy-induced Neuropathy
- Interventions
- Active non-invasive vagus nerve stimulation (nVNS); Sham non-invasive vagus nerve stimulation (nVNS); Home-based aerobic and resistance exercise program
- Ages
- adults, older adults
- Registry
- NCT07877558
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Patient-Reported Chemotherapy-Induced Neuropathy as Assessed by the Chinese Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20)
History
Primary completion expected
Expected to start
Registered