Luo Xiaozhen, Xie Lingling, Yang Lili, Chen Jing, Xian Jie, Tong Liping, Wan Yuming, Tang Yu, Zhu Jiang
Department I of Medical Oncology, Shangjin Nanfu Hospital, West China Hospital/Cancer CenterWest China Hospital Sichuan University, Chengdu, Sichuan Province, China.
Geriatric Center/School of Nursing, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.
Support Care Cancer. 2025 Jul 25;33(8):717. doi: 10.1007/s00520-025-09758-2.
To evaluate the feasibility and efficacy of patient-directed behavioral-physical intervention (BPI) for acute hiccups after chemotherapy in cancer patients.
In this prospective randomized controlled trial, cancer patients scheduled for chemotherapy were randomized into the BPI group and the control group. Patients in the BPI group were provided the Hiccup Knowledge Manual and instructional videos on six non-pharmacological behavioral-physical interventions for hiccups and were encouraged to use the interventions when they experienced acute chemotherapy-induced hiccups (CIH). The control group received routine medical attention. The primary endpoint was the median time to acute hiccup remission. The secondary endpoint was the incidence of anxiety and depression in patients and their family caregivers.
A total of 654 patients scheduled to receive chemotherapy were enrolled and randomly assigned (1:1) to the BPI group or the control group. After chemotherapy, 57 patients in the BPI group and 49 patients in the control group experienced acute hiccups. The median acute hiccup remission time was significantly shorter in the BPI group [0.17 h (95% CI 0.13 to 0.21 h)] than that in the control group [3.00 h (95% CI 1.48 to 4.52 h)] (P < 0.01). The mean anxiety and depression scores of patients were significantly lower in the BPI group than that in the control group (7.21 vs. 9.86, P < 0.01; 7.40 vs. 10.27, P < 0.01, respectively). Similarly, the average anxiety and depression scores of family caregivers were significantly lower in the BPI group than in the control group (3.91 vs. 8.31, P < 0.01; 4.30 vs. 8.90, P < 0.01, respectively).
Learning and self-directed implementation of behavioral-physical interventions have potential effects in shortening the median time to remission of acute CIH. It may also reduce anxiety and depression in patients and their family caregivers. Due to the limitations of this preliminary study, further research is warranted.
The study complied with relevant Chinese laws, rules, and regulations (Measures for the Ethical Review of Biomedical Research Involving Humans, etc.), as well as the WMA Declaration of Helsinki and the CIOMS International Ethics Guidelines for Human Biomedical Research, and followed the protocol approved by the medical ethics committee and the informed consent form to carry out clinical trials (research) to protect the health and rights of subjects. This study was approved by the Ethics Committee of Shangjin Nanfu Hospital West China Hospital and was registered in the World Health Organization (WHO) international clinical trials registered organization registered platform ( https://www.chictr.org.cn ; ChiCTR2400081049; February 21, 2024).
评估患者主导的行为-物理干预（BPI）对癌症患者化疗后急性呃逆的可行性和疗效。
在这项前瞻性随机对照试验中，计划接受化疗的癌症患者被随机分为BPI组和对照组。BPI组患者收到了《呃逆知识手册》以及关于六种呃逆非药物行为-物理干预的教学视频，并被鼓励在经历急性化疗引起的呃逆（CIH）时使用这些干预措施。对照组接受常规医疗护理。主要终点是急性呃逆缓解的中位时间。次要终点是患者及其家庭照顾者焦虑和抑郁的发生率。
共有654名计划接受化疗的患者入组并随机（1:1）分配到BPI组或对照组。化疗后，BPI组有57名患者、对照组有49名患者出现急性呃逆。BPI组急性呃逆缓解的中位时间[0.17小时（95%CI 0.13至0.21小时）]显著短于对照组[3.00小时（95%CI 1.48至4.52小时）]（P<0.01）。BPI组患者的平均焦虑和抑郁评分显著低于对照组（分别为7.21对9.86，P<0.01；7.40对10.27，P<0.01）。同样，BPI组家庭照顾者的平均焦虑和抑郁评分也显著低于对照组（分别为3.91对8.31，P<0.01；4.30对8.90，P<0.01）。
学习并自我实施行为-物理干预对缩短急性CIH缓解的中位时间有潜在作用。它还可能减轻患者及其家庭照顾者的焦虑和抑郁。由于这项初步研究存在局限性，有必要进行进一步研究。
本研究符合中国相关法律法规（《涉及人的生物医学研究伦理审查办法》等）以及世界医学协会《赫尔辛基宣言》和国际医学科学组织理事会《人体生物医学研究国际伦理准则》，并遵循医学伦理委员会批准的方案和知情同意书开展临床试验（研究），以保护受试者的健康和权益。本研究经四川大学华西医院上锦南府医院伦理委员会批准，并在世界卫生组织（WHO）国际临床试验注册机构注册平台（https://www.chictr.org.cn；ChiCTR2400081049；2024年2月21日）注册。
