Moderate to Severe Cancer PainNCT07616648
Effects of Opioid Drugs on Sleep and Emotion in Patients With Moderate to Severe Cancer Pain
An observational study of Moderate to Severe Cancer Pain, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Cancer Pain
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 15 Mar 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects included patients with moderate to severe cancer pain who meet the inclusion and exclusion criteria for this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou
About this study
Official title: 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.
- Conditions
- Moderate to Severe Cancer Pain
- Being tested
- No intervention
- Keywords
- cancer pain
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Pain Score
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.
Measured: Treatment day 1 to day 7,1-month follow-up, 3-month follow-up
Secondary outcomes (3)
Hamilton Anxiety Rating Scale (HAM-A) Score
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.
Measured: Treatment day 7,1-month follow-up, 3-month follow-up
Hamilton Depression Rating Scale (HAM-D) Score
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.
Measured: Treatment day 7,1-month follow-up, 3-month follow-up
Pittsburgh Sleep Quality Index (PSQI) Score
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.
Measured: Treatment day 7,1-month follow-up, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Apr 2026
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiying Feng, First Affiliated Hospital of Zhejiang University
- Investigators
- Zhiying, Principal investigator, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616648
- Sponsor's protocol ID
- [2026B] IIT. No. 0476
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No