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

27 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Moderate to Severe Cancer Pain

Intervenção / Tratamento

Outro: Sem intervenção

Tipo de estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Zhiying Feng, MD
Número de telefone: +86 13989881666
E-mail: fzy1972@zju.edu.cn

Locais de estudo

China
- - Hangzhou, China
    - Recrutamento
    - First affiliated Hospital of Zhejiang University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Numeric Rating Scale (NRS) Pain Score Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Hamilton Anxiety Rating Scale (HAM-A) Score Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

First Affiliated Hospital of Zhejiang University

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de abril de 2026

Conclusão Primária (Estimado)

15 de março de 2028

Conclusão do estudo (Estimado)

15 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de maio de 2026

Primeira postagem (Real)

1 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)