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Effects of Opioid Drugs on Sleep and Emotion in Patients With Moderate to Severe Cancer Pain

27 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Moderate to Severe Cancer Pain

Intervention / Traitement

Autre: Aucune intervention

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Zhiying Feng, MD
Numéro de téléphone: +86 13989881666
E-mail: fzy1972@zju.edu.cn

Lieux d'étude

Chine
- - Hangzhou, Chine
    - Recrutement
    - First affiliated Hospital of Zhejiang University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Numeric Rating Scale (NRS) Pain Score Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Hamilton Anxiety Rating Scale (HAM-A) Score Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

First Affiliated Hospital of Zhejiang University

Les enquêteurs

Chercheur principal: Zhiying, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 avril 2026

Achèvement primaire (Estimé)

15 mars 2028

Achèvement de l'étude (Estimé)

15 mars 2028

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

27 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)