このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。英語版ソーステキスト用。

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.

調査の概要

状態

募集

条件

Moderate to Severe Cancer Pain

介入・治療

他の：介入なし

研究の種類

観察的

入学 (推定)

200

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Zhiying Feng, MD
電話番号：+86 13989881666
メール：fzy1972@zju.edu.cn

研究場所

中国
- - Hangzhou、中国
    - 募集
    - First affiliated Hospital of Zhejiang University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The subjects included patients with moderate to severe cancer pain who meet the inclusion and exclusion criteria for this study.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Numeric Rating Scale (NRS) Pain Score 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Hamilton Anxiety Rating Scale (HAM-A) Score 時間枠：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 時間枠：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 時間枠：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.	Treatment day 7,1-month follow-up, 3-month follow-up

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

First Affiliated Hospital of Zhejiang University

捜査官

主任研究者：Zhiying、The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月15日

一次修了 (推定)

2028年3月15日

研究の完了 (推定)

2028年3月15日

試験登録日

最初に提出

2026年5月18日

QC基準を満たした最初の提出物

2026年5月27日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)