即将开始 NCT07877558

居家运动与迷走神经刺激用于化疗引起的神经病变

宫颈癌/妇科肿瘤不适用

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。