How opioids affect sleep and mood in adults with cancer pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, cross-sectional study plans to enroll about 200 adults aged 18–75 with moderate to severe cancer pain who use hydrocodone or oxycodone extended-release. It will collect baseline demographics, tumor history, and comorbidities via electronic patient-reported outcomes, along with pain measures, sleep indicators from wearable devices and sleep questionnaires, and psychological distress scales. Blood tests will be drawn to examine relevant biomarkers. Assessments occur at screening, 1 week, and 1- and 3-month follow-ups to observe changes over time in sleep, mood, and pain-related outcomes. No experimental treatment will be given; the study is observational and uses existing opioid therapy to explore associations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-75 years.
2. 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.
3. ECOG performance status score ≤ 3.
4. Possess basic cognitive function and ability to complete questionnaire-based assessments and wristband-based sleep monitoring.
5. Voluntarily sign the informed consent form and agree to comply with the study follow-up procedures.

Exclusion Criteria:

1. Severe cognitive impairment, history of psychiatric disorder, or language/communication barriers that precludes completion of the assessments.
2. History of opioid abuse or dependence; history of alcohol or non-opioid substance abuse.
3. Severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR \< 30 mL/min).
4. Life expectancy \< 3 months.
5. Women of childbearing age without effective contraception, or who are pregnant or breastfeeding.
6. Presence of other serious diseases or special conditions that, in the investigator's judgment, may interfere with the study outcomes.
7. Presence of contraindications to the study drug, such as paralytic ileus, chronic obstructive respiratory disease, or cor pulmonale.

Where it's running

• First Affiliated Hospital of Zhejiang University
  Hangzhou, China Recruiting

Study contacts

• Principal investigator: Zhiying — The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang
• Study coordinator: Zhiying Feng, MD
• Email: fzy1972@zju.edu.cn
• Phone: +86 13989881666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.