Effects of Opioid Drugs on Sleep and Emotion in Patients With Moderate to Severe Cancer Pain
2026年5月27日 更新者：Zhiying Feng、First Affiliated Hospital of Zhejiang University
Clinical Study on the Effects of Opioid Drugs on Sleep and Mood in Patients With Moderate to Severe Cancer Pain
This study is a multicenter cross-sectional observational study, aiming to include approximately 200 patients aged 18-75 years who are using hydrocodone sustained-release tablets or oxycodone sustained-release tablets for pain management of moderate to severe cancer pain.
Baseline information, tumor history, and comorbidities of the subjects will be collected through electronic patient-reported outcomes (ePRO), and the pain condition will be evaluated using BPI, acute pain assessment tools, etc. Sleep-related indicators will be collected using Huawei smart wearable devices and PSQI, ISI scales.
Psychological emotional states will be assessed using NCCN psychological distress thermometer, HAMA, HAMD, etc. Blood samples will also be collected for relevant tests.
The study sets up a screening baseline assessment period, a 1-week assessment period, and 1-month and 3-month follow-up periods after enrollment.
The changes in relevant indicators will be tracked throughout the process, aiming to quantify the association between pain and insomnia, anxiety and depression, and to verify the potential mediating role of sleep disorders between pain and emotional disorders, providing a basis for optimizing the comprehensive symptom management of cancer pain patients.
研究概览
研究类型
观察性的
注册 (估计的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhiying Feng, MD
- 电话号码：+86 13989881666
- 邮箱：fzy1972@zju.edu.cn
学习地点
-
-
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Hangzhou、中国
- 招聘中
- First affiliated Hospital of Zhejiang University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The subjects included patients with moderate to severe cancer pain who meet the inclusion and exclusion criteria for this study.
描述
Inclusion Criteria:
- Aged 18-75 years.
- Histopathologically or cytologically confirmed diagnosis of malignancy, with moderate to severe cancer-related pain (NRS ≥ 4 points), meeting the WHO three-step analgesic ladder principle, having received opioid analgesic therapy for at least one week with a stable dose and well-controlled pain.
- ECOG performance status score ≤ 3.
- Possess basic cognitive function and ability to complete questionnaire-based assessments and wristband-based sleep monitoring.
- Voluntarily sign the informed consent form and agree to comply with the study follow-up procedures.
Exclusion Criteria:
- Severe cognitive impairment, history of psychiatric disorder, or language/communication barriers that precludes completion of the assessments.
- History of opioid abuse or dependence; history of alcohol or non-opioid substance abuse.
- Severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR < 30 mL/min).
- Life expectancy < 3 months.
- Women of childbearing age without effective contraception, or who are pregnant or breastfeeding.
- Presence of other serious diseases or special conditions that, in the investigator's judgment, may interfere with the study outcomes.
- Presence of contraindications to the study drug, such as paralytic ileus, chronic obstructive respiratory disease, or cor pulmonale.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score
大体时间：Treatment day 1 to day 7,1-month follow-up, 3-month follow-up
|
Pain intensity was assessed using the 11-point Numeric Rating Scale (NRS).
The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater severity of pain.
The assessment was performed from day 1 to day 7 of the treatment phase.
|
Treatment day 1 to day 7,1-month follow-up, 3-month follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A) Score
大体时间：Treatment day 7,1-month follow-up, 3-month follow-up
|
Anxiety levels were assessed using the Hamilton Anxiety Rating Scale (HAM-A).
The HAM-A is a clinician-rated scale with a total score range of 0 to 56 points.
Higher scores indicate greater severity of anxiety symptoms.
The assessment was performed on day 7 of the treatment phase.
|
Treatment day 7,1-month follow-up, 3-month follow-up
|
|
Hamilton Depression Rating Scale (HAM-D) Score
大体时间：Treatment day 7,1-month follow-up, 3-month follow-up
|
Depression levels were assessed using the Hamilton Depression Rating Scale (HAM-D).
The HAM-D is a clinician-rated scale with a total score range of 0 to 52 points (17-item version).
Higher scores indicate greater severity of depressive symptoms.
The assessment was performed on day 7 of the treatment phase.
|
Treatment day 7,1-month follow-up, 3-month follow-up
|
|
Pittsburgh Sleep Quality Index (PSQI) Score
大体时间：Treatment day 7,1-month follow-up, 3-month follow-up
|
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI).
The total score ranges from 0 to 21 points.
Higher scores indicate poorer sleep quality.
The assessment was performed from day 1 to day 7 of the treatment phase.
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Treatment day 7,1-month follow-up, 3-month follow-up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Zhiying、The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月15日
初级完成 (估计的)
2028年3月15日
研究完成 (估计的)
2028年3月15日
研究注册日期
首次提交
2026年5月18日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.