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NCT Number: NCT07616648

Effects of Opioid Drugs on Sleep and Emotion 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.

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Key information

Conditions

Moderate to Severe Cancer Pain Cancer Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Numeric Rating Scale (NRS) Pain Score

    Time frame: 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.

Secondary outcomes

  1. Hamilton Anxiety Rating Scale (HAM-A) Score

    Time frame: 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.

  2. Hamilton Depression Rating Scale (HAM-D) Score

    Time frame: 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.

  3. Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiying Feng, MD

CONTACT

[email protected]

+86 13989881666

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Clinical Study on the Effects of Opioid Drugs on Sleep and Mood in Patients With Moderate to Severe Cancer Pain

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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