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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effects of Opioid Drugs on Sleep and Mood in Patients With Moderate to Severe Cancer Pain
- ClinicalTrials.gov ID
- NCT07616648
- Acronym / sponsor ID
- [2026B] IIT. No. 0476
- Conditions
- Moderate to Severe Cancer Pain
- Keywords
- cancer pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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.
3 secondary outcomes
Hamilton Anxiety Rating Scale (HAM-A) Score
Time frame: Treatment day 7,1-month follow-up, 3-month follow-up
Hamilton Depression Rating Scale (HAM-D) Score
Time frame: Treatment day 7,1-month follow-up, 3-month follow-up
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Treatment day 7,1-month follow-up, 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiying principal investigator
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Cancer Pain, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiying Feng, MD (+86 13989881666, fzy1972@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) Pain Score (time frame: Treatment day 1 to day 7,1-month follow-up, 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.