头颈癌幸存者口腔健康改善（OHHNC研究）：一项多中心双臂随机对照试验的研究方案。
Improved oral health in head and neck cancer survivors (OHHNC study): a study protocol for a multicentre two-armed randomised controlled trial.
文献信息
| PMID | 42717322 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Sandra Einarsson |
| 作者单位 | Department of Food, Nutrition and Culinary Science, Umeå University, Umeå, Sweden. |
| 期刊 | BMC cancer |
| SCI 分区 | Q2 |
| IF | 4.1 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
背景： 头颈癌包括一组影响上呼吸消化道解剖部位的异质性肿瘤。治疗通常涉及手术以及放疗或放化疗。这些治疗与显著的发病率相关，并可能对口腔健康产生长期不良影响。口腔并发症可对健康相关生活质量、营养状况以及社交和工作相关功能产生负面影响。目的是评估一项旨在预防或减轻晚期口腔后遗症的口腔健康护理方案，并评估其对健康相关生活质量、口腔健康、工作能力、营养状况、医疗相关经济成本和心理幸福感的影响。
方法： 这是一项瑞典多中心、双臂、优效性随机对照试验的研究方案，已获得瑞典伦理审查局伦理批准。患者纳入于2025年9月开始，预期样本为300名参与者。计划接受头颈癌（口腔、口咽、喉III期和IV期、下咽、鼻咽、唾液腺或原发不明）根治性治疗的成年患者（≥18岁）按1:1随机分配至口腔健康护理方案（干预）或标准护理。
排除标准： 严重酒精中毒、认知障碍或无法理解瑞典语。参与者在癌症治疗开始前以及4次随访时接受随访：治疗完成后6个月，以及6个月随访后1年、2年和3年。主要结局指标是健康相关生活质量。次要结局包括定量口腔健康指标、重返工作、营养状况、医疗相关经济成本，以及关注自报口腔健康和心理幸福感（抑郁、焦虑和压力）及自我效能感的患者报告结局指标。
讨论： 头颈癌幸存者的口腔健康随访往往缺乏一致性和统一性。迄今为止，很少有头颈癌幸存者的口腔健康护理干预在随机对照试验框架内得到评估。研究结果有可能为临床实践提供信息，并有助于在头颈癌幸存者的常规随访中制定更整合、基于证据的口腔医疗策略，其总体目标是改善其口腔健康和长期生活质量。
试验注册： ClinicalTrials.gov NCT07173270，日期2025年9月15日。
英文摘要
BACKGROUND: Head and neck cancer comprises a heterogeneous group of tumours affecting anatomical sites of the upper aerodigestive tract. Treatment often involves surgery and either radiotherapy or chemoradiotherapy. These treatments are associated with substantial morbidity and may have long-lasting adverse effects on oral health. Oral complications can negatively affect health-related quality of life, nutritional status, and social and work-related functioning. The aim is to evaluate an oral health care programme designed to prevent or mitigate late oral sequalae, and to assess its impact on health-related quality of life, oral health, work ability, nutritional status, healthcare-related economic costs, and psychological well-being.
METHODS: This is a study protocol for a Swedish multicentre, two-armed, superiority randomised controlled trial that has been ethically approved by the Swedish Ethical Review Authority. Patient inclusion commenced in September 2025, with an intended sample of 300 participants. Adult patients (≥ 18 years) planned for curative-intent treatment for head and neck cancer (oral cavity, oropharynx, larynx stage III and IV, hypopharynx, nasopharynx, salivary gland, or unknown primary) are randomised (1:1) to either an oral health care programme (intervention) or standard of care.
EXCLUSION CRITERIA: severe alcoholism, cognitive impairment, or inability to understand the Swedish language. Participants are followed before the start of cancer treatment and at 4 follow-ups: 6 months after completion of treatment, and 1, 2, and 3 years after the 6-month follow-up. The primary outcome measure is health-related quality of life. Secondary outcomes include quantitative oral health indicators, return to work, nutritional status, healthcare-related economic costs, and patient-reported outcome measures focusing on self-reported oral health and psychological well-being (depression, anxiety and stress), and self-efficacy.
DISCUSSION: Oral health follow-up for head and neck cancer survivors often lacks consistency and uniformity. To date, few oral health care interventions for head and neck cancer survivors have been evaluated within the framework of a randomised controlled trial. The findings have the potential to inform clinical practice and contribute to the development of more integrated, evidence-based oral healthcare strategies within routine follow-up for head and neck cancer survivors, with the overarching goal of improving their oral health and long-term quality of life.
TRIAL REGISTRATION: ClinicalTrials.gov NCT07173270, date 15/9/2025.