背景:研究强调居家运动对患有化疗引起的神经病变(CIN)的癌症康复者具有潜在益处;然而,其在缓解CIN相关感觉运动功能障碍及症状方面的效果并不一致,且一般较为温和。非侵入性迷走神经刺激(nVNS)已成为CIN复康中一种有前景的辅助疗法。
适应症:Chemotherapy-induced Neuropathy
入组条件
纳入标准
- Hong Kong residents who can communicate in Cantonese, Mandarin, or English;
- Aged 18 years or older;
- Cancer survivors with complete disease remission after radical treatment;
- Completed a chemotherapy regimen with radical intent that included at least one of the following agents for a minimum of 3 months:
- Platinum compounds (e.g., cisplatin, carboplatin, oxaliplatin);
- Taxanes (e.g., paclitaxel, docetaxel);
- Have CIN of at least grade 2 assessed by a clinician based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE 5.0), or self-rate ≥ 2 points on at least one item in the 4-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire;
- Physically capable of engaging in exercise and assessments, as determined by the ability to complete the 6MWT;
- Able to provide written informed consent.
排除标准
- Known history of peripheral neuropathy or related symptoms prior to chemotherapy;
- History of heart disease;
- Bradycardia (heart rate \< 60 beats per minute);
- Pregnancy;
- Presence of active implants, such as cardiac pacemakers, cochlear implants, and implanted neurostimulators;
- Known metastasis to the central or peripheral nervous system;
- Any physical or mental handicap;
- History of alcohol or illegal drug abuse;
- Using a hearing aid device on the left ear;
- Receiving other non-pharmacological treatments for CIN within the past 2 months;
- Engaging in over 30 minutes of exercise for 2 or more days per week prior to enrollment;
- Any wound, infection, skin allergy, or deformity in the left ear;
- Any other medical contraindication to exercise and/or nVNS as determined by the treating oncologist.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年11月5日。