Cancer PainNCT07421674
Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency
An observational study of Cancer Pain and Renal Insufficiency Chronic, run by Taian Cancer Hospital at 1 site in China.
Trial summary
This clinical study aims to understand whether domestic hydromorphinone sustained-release tablets are effective and safe in treating moderate to severe cancer pain in elderly patients with renal insufficiency. It will also understand key safety concerns, especially regarding renal function and neurotoxicity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer Pain, Renal Insufficiency Chronic, Hydromorphone Use
- Type of treatment
- Pill or oral medicine
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 31 Dec 2028
- How long will I take part?
- 4 Weeks
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Study participants will be selected from the patient population presenting at the Oncology Department of Taian City Tumor Hospital, a regional tertiary cancer care center in Shandong Province, China. Recruitment will specifically target older adult patients with cancer who are being evaluated for and initiate standardized opioid therapy for moderate-to-severe cancer pain at this institution.
Who may be able to join
- Age ≥ 65 years.
- Pathologically or cytologically confirmed malignant tumor.
- Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4).
- Renal function meeting one of the following criteria at baseline:
- 1）Mild-to-moderate renal insufficiency group: 30 mL/min/1.73m² ≤ estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m².
- 2）Normal renal function group: eGFR ≥ 90 mL/min/1.73m². 5.Expected survival period ≥ 3 months. 6.Ability to take oral medication and cooperate with study assessments. 7.Willing to participate voluntarily and able to provide signed informed consent.
Who cannot join
- Severe renal insufficiency (eGFR < 30 mL/min/1.73m²) or requirement for renal replacement therapy.
- Severe hepatic insufficiency (alanine aminotransferase / aspartate aminotransferase ≥ 2.5 times the upper limit of normal or Child-Pugh Class C).
- Paralytic ileus.
- Pain of unclear origin or pain that is solely acute/incident pain.
- Symptoms or history of diseases such as intracranial hypertension, head injury, cerebral aneurysm, or other central nervous system disorders.
- Symptoms of prostatic hypertrophy, thyroid dysfunction, or urethral stricture. Symptoms of asthma, respiratory obstruction, or respiratory failure.
Show all 10Show fewer
- Known allergy or hypersensitivity to hydromorphone or oxycodone.
- Use of monoamine oxidase inhibitors within 14 days prior to enrollment.
- Participation in any other clinical trial within 1 month prior to enrollment.
- Any other condition considered by the investigator as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Junjun Hou contact
China1 site
Tai'an Caner Hospital
Tai’an, Shandong, 271000
Xiaomei He, +86 13705383066, yifanmami@126.com
Junjun Hou
About this study
Official title: Application Research of Hydromorphinone Sustained-release Tablets in the Treatment of Elderly Patients With Cancer Pain Accompanied by Renal Insufficiency
This clinical study aims to understand whether domestic hydromorphinone sustained-release tablets are effective and safe in treating moderate to severe cancer pain in elderly patients with renal insufficiency.
It will also understand key safety concerns, especially regarding renal function and neurotoxicity.
Read more
The main questions it aims to answer include:1. Can hydromorphinone sustained-release tablets effectively relieve the pain of such patients and improve their quality of life?2. During the treatment period, what effect does this drug have on renal function (measured by eGFR)? 3. In this specific population, what are the occurrence and characteristics of neurotoxicity and other side effects induced by opioids? Researchers will compare elderly cancer pain patients with renal insufficiency with those with normal renal function (both receiving the study drug treatment) to observe whether there are differences in efficacy and safety results.
Participants will:
Receive a standardized treatment plan: First, subcutaneous injection of hydromorphinone injection for dose titration, and then switch to daily oral administration of hydromorphinone sustained-release tablets for 4 weeks.
Visit the clinic for assessment and examination (including renal function tests) during the baseline period, on the 7th day, and at the weekends of the 2nd, 3rd, and 4th days.
Regularly monitor and record the degree of pain, the occurrence of explosive pain, the use of medication, and any side effects.
Read the detailed description
- The research background and principle of elderly cancer patients are often faced with moderately severe pain, the pain management is particularly complex in this group. The physiological functions of the elderly decline, often accompanied by a decrease in renal function, which significantly limits the safe use of many standard opioid analgesics, such as morphine. The active metabolites of morphine tend to accumulate in patients with renal insufficiency, increasing the risk of neurotoxicity. Another commonly used drug, oxycodone, may cause a relatively high incidence of gastrointestinal adverse reactions. Hydromorphinone is a potent opioid drug, and its pharmacological properties may offer a solution to this predicament. It is mainly metabolized through liver glucoaldehyde acidification, generating inactive metabolites, and does not rely on the complex cytochrome P450 enzyme system. Therefore, the risk of drug interactions is relatively low, and theoretically, it has a smaller impact on kidney function, especially suitable for elderly patients with reduced kidney function. However, although there have been some studies on imported hydromoradone preparations, domestic hydromoradone hydrochloride sustained-release tablets (such as Ruining ®) have lacked prospective and systematic clinical evidence in the cancer pain population characterized by dual risk factors of "old age" and "renal insufficiency" since their launch. This study aims to fill this crucial gap in evidence.
- The research design and methodology described in this study using prospective, observational cohort design. Unlike randomized controlled trials, this study aims to observe the natural outcomes of standardized treatment regimens in elderly patients with different renal function statuses under real-world conditions. All eligible patients enrolled in the group will receive a unified analgesic treatment plan based on international authoritative guidelines: Firstly, subcutaneous injection titration of hydromorphinone injection will be performed to quickly determine the individualized dose required for pain control; After the pain stabilized, it was uniformly converted to the same dose of domestic hydromorphinone sustained-release tablets for oral maintenance treatment once daily. The total treatment observation period was 4 weeks. The key to the research lies in "hierarchical comparison". Before treatment, the investigators will naturally divide the patients into two cohorts based on their estimated glomerular filtration rate (eGFR, a core indicator for evaluating renal function) : the "Elderly with renal insufficiency group" and the "Elderly with normal renal function Group". In this way, the investigators can directly compare the performance differences of the drug in these two types of people with different physiological states. The sample size calculation (planned to include a total of 62 patients) was based on the primary safety endpoint - the change in eGFR values relative to baseline at week 4 of treatment. A clinically significant effect size was preset during the calculation, and sufficient statistical certainty was ensured to guarantee the reliability of the research results.
- The core assessment and monitoring framework in addition to conventional pain intensity assessment (NRS) adopting digital grading method, quality of living survey and common adverse reactions, this research established dual core security monitoring system: Dynamic monitoring of renal function: Serum creatinine will be systematically detected and eGFR calculated at five time points before and during treatment. This is not only used to compare the differences between groups, but more importantly, to monitor the dynamic trajectory of each patient's individual renal function and promptly detect any clinically significant signs of deterioration. Active screening for neurotoxicity (OIN) : In response to neurotoxic symptoms such as delirium, drowsiness, and myoclonus that may be caused by opioids, the study will conduct active screening and assessment once a week using a series of standardized scales, for example, using the Confusion Assessment method (CAM) to screen for delirium. This systematic monitoring aims to capture the incidence and characteristics of OIN more precisely.
- Data analysis, statistical analysis strategy will use advanced statistical models to cope with the complexity of clinical data. For the primary endpoint (eGFR change), covariance analysis will be used to correct for baseline eGFR differences during statistical analysis, thereby more purer assessing the impact of the treatment itself on renal function. For data such as pain scores that are repeatedly measured at different time points, generalized estimating equations will be used for analysis to effectively utilize all the information of the longitudinal data. Furthermore, if a sufficient number of neurotoxic events are observed in the study, the investigators will conduct an exploratory analysis and attempt to construct a clinical risk prediction tool (nomogram) using a multi-factor regression model to identify high-risk patients with OIN.
- The risk control and clinical patient safety is the primary consideration. The research protocol is equipped with clear safety suspension rules: once a patient's eGFR drops by more than 30% from baseline or falls within the range of severe renal failure, the study medication will be immediately suspended and a multidisciplinary consultation will be initiated. For patients with moderate to severe neurotoxicity, there are already pre-established alternative analgesic regimens (such as switching to fentanyl transdermal patches). The entire research was carried out on the "Standardized Cancer Pain Treatment Demonstration Ward" platform of Tai 'an Cancer Hospital. This team has mature cancer pain management and emergency response procedures.
- The value of the research and production in this study beyond the simple answer of "analgesia is effective", focus on "in the vulnerable groups is safe" more pressing clinical problem. Its achievements are expected to provide value on three levels:
Direct evidence: It provides the first prospective efficacy and safety data for the application of domestic hydromoradone sustained-release tablets in elderly patients with renal insufficiency.
Clinical guidance: Clarify the adverse reaction spectrum of this drug in this population, especially its specific effects on renal function and the nervous system, to provide a basis for clinical dose adjustment and risk early warning.
Methodological demonstration: Demonstrate how to answer practical questions about medication safety for specific high-risk populations through rigorous observational studies and advanced statistical methods.
Through this research, the investigators hope to provide decision support based on localized drugs and high-level evidence for clinicians when treating this complex and vulnerable patient group, ultimately promoting the precision and safety improvement of cancer pain management in the elderly.
- Conditions
- Cancer Pain, Renal Insufficiency Chronic, Hydromorphone Use
- Keywords
- Cancer Pain, Renal Insufficiency, Aged, Hydromorphone, Opioid-Induced Neurotoxicity
- Medical subject headings
- Cancer Pain, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone - Renal Insufficiency Group | Elder cancer pain patients with mild to moderate renal insufficiency at enrollment, defined by an estimated glomerular filtration rate (eGFR) range of 30 ≤ eGFR < 90 mL/min/1.73m². They receive standardized Hydromorphone Sustained-Release Tablet treatment. | |
| Hydromorphone - Normal Renal Function Group | Elder cancer pain patients with normal renal function at enrollment, defined by an estimated glomerular filtration rate (eGFR) of eGFR ≥ 90 mL/min/1.73m². They receive the identical standardized Hydromorphone Sustained-Release Tablet treatment as Cohort 1, serving as the reference comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in estimated glomerular filtration rate (eGFR) from baseline at the end of the 4th week of treatmentDetailed
The estimated glomerular filtration rate (eGFR) is a validated indicator of kidney function. It is calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, which incorporates the patient's age and sex. All values are normalized to body surface area and expressed as mL/min/1.73m². On this scale, higher eGFR values indicate better kidney function, while lower values indicate impaired kidney function.
The change in eGFR is defined as the value measured at week 4 minus the value measured at baseline (immediately prior to treatment initiation).
A negative change value indicates a decrease in eGFR from baseline, representing a decline in kidney function.
A positive change value indicates an increase in eGFR from baseline, representing an improvement in kidney function.
eGFR is measured from venous blood samples collected at baseline and at week 4.
Measured: From the start of maintenance treatment with hydromorphinone sustained-release tablets until the end of the fourth week of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Taian Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian'guo Wang, Taian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421674
- Sponsor's protocol ID
- 2025022
- Other IDs
- YXH2025JS126
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the primary publication (including demographics, baseline clinical characteristics, serial eGFR measurements, pain scores, and safety outcomes) will be shared. Supporting documents like the study protocol and statistical analysis plan will also be provided. Data will become available 12 months after article publication to researchers who submit a methodologically sound proposal and sign a data use agreement.
Publications
Zheng MD, Li YX, Wang ZY, Ma H, Wang Y, Qiao TT, Krasovitsky MS, Tatar C, Karlekar M, Yan J. Patient-controlled analgesia with hydromorphone treatment for advanced colon cancer with severe pain in an older adult patient: a case report and literature review. J Gastrointest Oncol. 2024 Oct 31;15(5):2330-2337. doi: 10.21037/jgo-24-713. Epub 2024 Oct 29.
PubMed 39554558Lin R, Lin S, Feng S, Wu Q, Fu J, Wang F, Li H, Li X, Zhang G, Yao Y, Xin M, Lai T, Lv X, Chen Y, Yang S, Lin Y, Hong L, Cai Z, Wang J, Lin G, Lin S, Zhao S, Zhu J, Huang C. Comparing Patient-Controlled Analgesia Versus Non-PCA Hydromorphone Titration for Severe Cancer Pain: A Randomized Phase III Trial. J Natl Compr Canc Netw. 2021 Aug 3;19(10):1148-1155. doi: 10.6004/jnccn.2020.7699.
PubMed 34343968Hanna M, Thipphawong J; 118 Study Group. A randomized, double-blind comparison of OROS(R) hydromorphone and controlled-release morphine for the control of chronic cancer pain. BMC Palliat Care. 2008 Oct 31;7:17. doi: 10.1186/1472-684X-7-17.
PubMed 18976472van Ojik AL, Jansen PA, Brouwers JR, van Roon EN. Treatment of chronic pain in older people: evidence-based choice of strong-acting opioids. Drugs Aging. 2012 Aug 1;29(8):615-25. doi: 10.2165/11632620-000000000-00000.
PubMed 22765848Kullgren J, Le V, Wheeler W. Incidence of hydromorphone-induced neuroexcitation in hospice patients. J Palliat Med. 2013 Oct;16(10):1205-9. doi: 10.1089/jpm.2012.0467. Epub 2013 Aug 9.
PubMed 23930920Carter NJ, Keating GM. OROS hydromorphone prolonged release: a review of its use in the management of chronic, moderate to severe pain. CNS Drugs. 2010 Apr;24(4):337-61. doi: 10.2165/11202580-000000000-00000.
PubMed 20297858Odoma VA, Pitliya A, AlEdani E, Bhangu J, Javed K, Manshahia PK, Nahar S, Kanda S, Chatha U, Mohammed L. Opioid Prescription in Patients With Chronic Kidney Disease: A Systematic Review of Comparing Safety and Efficacy of Opioid Use in Chronic Kidney Disease Patients. Cureus. 2023 Sep 18;15(9):e45485. doi: 10.7759/cureus.45485. eCollection 2023 Sep.
PubMed 37727840Liu L, Xu M, Wang J, Hu Y, Huang Z. Research Progress of Hydromorphone in Clinical Application. Physiol Res. 2025 Mar 21;74(1):41-48. doi: 10.33549/physiolres.935354.
PubMed 40116549Lim KH, Nguyen NN, Qian Y, Williams JL, Lui DD, Bruera E, Yennurajalingam S. Frequency, Outcomes, and Associated Factors for Opioid-Induced Neurotoxicity in Patients with Advanced Cancer Receiving Opioids in Inpatient Palliative Care. J Palliat Med. 2018 Dec;21(12):1698-1704. doi: 10.1089/jpm.2018.0169. Epub 2018 Sep 27.
PubMed 30260731Kim YS, Kim WY. Reversible decorrelation method for progressive transmission of 3-D medical image. IEEE Trans Med Imaging. 1998 Jun;17(3):383-94. doi: 10.1109/42.712128.
PubMed 9735902Owsiany MT, Hawley CE, Triantafylidis LK, Paik JM. Opioid Management in Older Adults with Chronic Kidney Disease: A Review. Am J Med. 2019 Dec;132(12):1386-1393. doi: 10.1016/j.amjmed.2019.06.014. Epub 2019 Jul 8.
PubMed 31295441Kimmel PL, Fwu CW, Abbott KC, Eggers AW, Kline PP, Eggers PW. Opioid Prescription, Morbidity, and Mortality in United States Dialysis Patients. J Am Soc Nephrol. 2017 Dec;28(12):3658-3670. doi: 10.1681/ASN.2017010098. Epub 2017 Sep 21.
PubMed 28935654Roy PJ, Weltman M, Dember LM, Liebschutz J, Jhamb M; HOPE Consortium. Pain management in patients with chronic kidney disease and end-stage kidney disease. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):671-680. doi: 10.1097/MNH.0000000000000646.
PubMed 32941189Mullins S, Hosseini F, Gibson W, Thake M. Physiological changes from ageing regarding pain perception and its impact on pain management for older adults. Clin Med (Lond). 2022 Jul;22(4):307-310. doi: 10.7861/clinmed.22.4.phys.
PubMed 35882493Domenichiello AF, Ramsden CE. The silent epidemic of chronic pain in older adults. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jul 13;93:284-290. doi: 10.1016/j.pnpbp.2019.04.006. Epub 2019 Apr 17.
PubMed 31004724
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Research of Hydromorphinone Sustained-release Tablets in the Treatment of Elderly Patients With Cancer Pain Accompanied by Renal Insufficiency
- ClinicalTrials.gov ID
- NCT07421674
- Acronym / sponsor ID
- 2025022
- Conditions
- Cancer Pain, Renal Insufficiency Chronic, Hydromorphone Use
- Keywords
- Cancer Pain, Renal Insufficiency, Aged, Hydromorphone, Opioid-Induced Neurotoxicity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Taian Cancer HospitalUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Feb 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 clinical study aims to understand whether domestic hydromorphinone sustained-release tablets are effective and safe in treating moderate to severe cancer pain in elderly patients with renal insufficiency.
It will also understand key safety concerns, especially regarding renal function and neurotoxicity.
The main questions it aims to answer include:1. Can hydromorphinone sustained-release tablets effectively relieve the pain of such patients and improve their quality of life?2. During the treatment period, what effect does this drug have on renal function (measured by eGFR)? 3. In this specific population, what are the occurrence and characteristics of neurotoxicity and other side effects induced by opioids? Researchers will compare elderly cancer pain patients with renal insufficiency with those with normal renal function (both receiving the study drug treatment) to observe whether there are differences in efficacy and safety results.
Participants will:
Receive a standardized treatment plan: First, subcutaneous injection of hydromorphinone injection for dose titration, and then switch to daily oral administration of hydromorphinone sustained-release tablets for 4 weeks.
Visit the clinic for assessment and examination (including renal function tests) during the baseline period, on the 7th day, and at the weekends of the 2nd, 3rd, and 4th days.
Regularly monitor and record the degree of pain, the occurrence of explosive pain, the use of medication, and any side effects.
Detailed description
- The research background and principle of elderly cancer patients are often faced with moderately severe pain, the pain management is particularly complex in this group. The physiological functions of the elderly decline, often accompanied by a decrease in renal function, which significantly limits the safe use of many standard opioid analgesics, such as morphine. The active metabolites of morphine tend to accumulate in patients with renal insufficiency, increasing the risk of neurotoxicity. Another commonly used drug, oxycodone, may cause a relatively high incidence of gastrointestinal adverse reactions. Hydromorphinone is a potent opioid drug, and its pharmacological properties may offer a solution to this predicament. It is mainly metabolized through liver glucoaldehyde acidification, generating inactive metabolites, and does not rely on the complex cytochrome P450 enzyme system. Therefore, the risk of drug interactions is relatively low, and theoretically, it has a smaller impact on kidney function, especially suitable for elderly patients with reduced kidney function. However, although there have been some studies on imported hydromoradone preparations, domestic hydromoradone hydrochloride sustained-release tablets (such as Ruining ®) have lacked prospective and systematic clinical evidence in the cancer pain population characterized by dual risk factors of "old age" and "renal insufficiency" since their launch. This study aims to fill this crucial gap in evidence.
- The research design and methodology described in this study using prospective, observational cohort design. Unlike randomized controlled trials, this study aims to observe the natural outcomes of standardized treatment regimens in elderly patients with different renal function statuses under real-world conditions. All eligible patients enrolled in the group will receive a unified analgesic treatment plan based on international authoritative guidelines: Firstly, subcutaneous injection titration of hydromorphinone injection will be performed to quickly determine the individualized dose required for pain control; After the pain stabilized, it was uniformly converted to the same dose of domestic hydromorphinone sustained-release tablets for oral maintenance treatment once daily. The total treatment observation period was 4 weeks. The key to the research lies in "hierarchical comparison". Before treatment, the investigators will naturally divide the patients into two cohorts based on their estimated glomerular filtration rate (eGFR, a core indicator for evaluating renal function) : the "Elderly with renal insufficiency group" and the "Elderly with normal renal function Group". In this way, the investigators can directly compare the performance differences of the drug in these two types of people with different physiological states. The sample size calculation (planned to include a total of 62 patients) was based on the primary safety endpoint - the change in eGFR values relative to baseline at week 4 of treatment. A clinically significant effect size was preset during the calculation, and sufficient statistical certainty was ensured to guarantee the reliability of the research results.
- The core assessment and monitoring framework in addition to conventional pain intensity assessment (NRS) adopting digital grading method, quality of living survey and common adverse reactions, this research established dual core security monitoring system: Dynamic monitoring of renal function: Serum creatinine will be systematically detected and eGFR calculated at five time points before and during treatment. This is not only used to compare the differences between groups, but more importantly, to monitor the dynamic trajectory of each patient's individual renal function and promptly detect any clinically significant signs of deterioration. Active screening for neurotoxicity (OIN) : In response to neurotoxic symptoms such as delirium, drowsiness, and myoclonus that may be caused by opioids, the study will conduct active screening and assessment once a week using a series of standardized scales, for example, using the Confusion Assessment method (CAM) to screen for delirium. This systematic monitoring aims to capture the incidence and characteristics of OIN more precisely.
- Data analysis, statistical analysis strategy will use advanced statistical models to cope with the complexity of clinical data. For the primary endpoint (eGFR change), covariance analysis will be used to correct for baseline eGFR differences during statistical analysis, thereby more purer assessing the impact of the treatment itself on renal function. For data such as pain scores that are repeatedly measured at different time points, generalized estimating equations will be used for analysis to effectively utilize all the information of the longitudinal data. Furthermore, if a sufficient number of neurotoxic events are observed in the study, the investigators will conduct an exploratory analysis and attempt to construct a clinical risk prediction tool (nomogram) using a multi-factor regression model to identify high-risk patients with OIN.
- The risk control and clinical patient safety is the primary consideration. The research protocol is equipped with clear safety suspension rules: once a patient's eGFR drops by more than 30% from baseline or falls within the range of severe renal failure, the study medication will be immediately suspended and a multidisciplinary consultation will be initiated. For patients with moderate to severe neurotoxicity, there are already pre-established alternative analgesic regimens (such as switching to fentanyl transdermal patches). The entire research was carried out on the "Standardized Cancer Pain Treatment Demonstration Ward" platform of Tai 'an Cancer Hospital. This team has mature cancer pain management and emergency response procedures.
- The value of the research and production in this study beyond the simple answer of "analgesia is effective", focus on "in the vulnerable groups is safe" more pressing clinical problem. Its achievements are expected to provide value on three levels:
Direct evidence: It provides the first prospective efficacy and safety data for the application of domestic hydromoradone sustained-release tablets in elderly patients with renal insufficiency.
Clinical guidance: Clarify the adverse reaction spectrum of this drug in this population, especially its specific effects on renal function and the nervous system, to provide a basis for clinical dose adjustment and risk early warning.
Methodological demonstration: Demonstrate how to answer practical questions about medication safety for specific high-risk populations through rigorous observational studies and advanced statistical methods.
Through this research, the investigators hope to provide decision support based on localized drugs and high-level evidence for clinicians when treating this complex and vulnerable patient group, ultimately promoting the precision and safety improvement of cancer pain management in the elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone - Renal Insufficiency Group | – | –Elder cancer pain patients with mild to moderate renal insufficiency at enrollment, defined by an estimated glomerular filtration rate (eGFR) range of 30 ≤ eGFR < 90 mL/min/1.73m². They receive standardized Hydromorphone Sustained-Release Tablet treatment. |
| Hydromorphone - Normal Renal Function Group | – | –Elder cancer pain patients with normal renal function at enrollment, defined by an estimated glomerular filtration rate (eGFR) of eGFR ≥ 90 mL/min/1.73m². They receive the identical standardized Hydromorphone Sustained-Release Tablet treatment as Cohort 1, serving as the reference comparison group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Study participants will be selected from the patient population presenting at the Oncology Department of Taian City Tumor Hospital, a regional tertiary cancer care center in Shandong Province, China. Recruitment will specifically target older adult patients with cancer who are being evaluated for and initiate standardized opioid therapy for moderate-to-severe cancer pain at this institution.
Key inclusion criteria (6 listed)
- Age ≥ 65 years.
- Pathologically or cytologically confirmed malignant tumor.
- Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4).
- Renal function meeting one of the following criteria at baseline:
- 1）Mild-to-moderate renal insufficiency group: 30 mL/min/1.73m² ≤ estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m².
Key exclusion criteria (10 listed)
- Severe renal insufficiency (eGFR < 30 mL/min/1.73m²) or requirement for renal replacement therapy.
- Severe hepatic insufficiency (alanine aminotransferase / aspartate aminotransferase ≥ 2.5 times the upper limit of normal or Child-Pugh Class C).
- Paralytic ileus.
- Pain of unclear origin or pain that is solely acute/incident pain.
- Symptoms or history of diseases such as intracranial hypertension, head injury, cerebral aneurysm, or other central nervous system disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The changes in estimated glomerular filtration rate (eGFR) from baseline at the end of the 4th week of treatmentDetailed
Time frame: From the start of maintenance treatment with hydromorphinone sustained-release tablets until the end of the fourth week of treatment.
The estimated glomerular filtration rate (eGFR) is a validated indicator of kidney function. It is calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, which incorporates the patient's age and sex. All values are normalized to body surface area and expressed as mL/min/1.73m². On this scale, higher eGFR values indicate better kidney function, while lower values indicate impaired kidney function. The change in eGFR is defined as the value measured at week 4 minus the value measured at baseline (immediately prior to treatment initiation). A negative change value indicates a decrease in eGFR from baseline, representing a decline in kidney function. A positive change value indicates an increase in eGFR from baseline, representing an improvement in kidney function. eGFR is measured from venous blood samples collected at baseline and at week 4.
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 25 Feb 2026.
- Background: PubMed 39554558Zheng MD, Li YX, Wang ZY, Ma H, Wang Y, Qiao TT, Krasovitsky MS, Tatar C, Karlekar M, Yan J. Patient-controlled analgesia with hydromorphone treatment for advanced colon cancer with severe pain in an older adult patient: a case report and literature review. J Gastrointest Oncol. 2024 Oct 31;15(5):2330-2337. doi: 10.21037/jgo-24-713. Epub 2024 Oct 29.
- Background: PubMed 34343968Lin R, Lin S, Feng S, Wu Q, Fu J, Wang F, Li H, Li X, Zhang G, Yao Y, Xin M, Lai T, Lv X, Chen Y, Yang S, Lin Y, Hong L, Cai Z, Wang J, Lin G, Lin S, Zhao S, Zhu J, Huang C. Comparing Patient-Controlled Analgesia Versus Non-PCA Hydromorphone Titration for Severe Cancer Pain: A Randomized Phase III Trial. J Natl Compr Canc Netw. 2021 Aug 3;19(10):1148-1155. doi: 10.6004/jnccn.2020.7699.
- Background: PubMed 18976472Hanna M, Thipphawong J; 118 Study Group. A randomized, double-blind comparison of OROS(R) hydromorphone and controlled-release morphine for the control of chronic cancer pain. BMC Palliat Care. 2008 Oct 31;7:17. doi: 10.1186/1472-684X-7-17.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the primary publication (including demographics, baseline clinical characteristics, serial eGFR measurements, pain scores, and safety outcomes) will be shared. Supporting documents like the study protocol and statistical analysis plan will also be provided. Data will become available 12 months after article publication to researchers who submit a methodologically sound proposal and sign a data use agreement.
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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.
Junjun Hou contact
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 Cancer Pain and Renal Insufficiency Chronic, run by Taian Cancer Hospital 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 25 Feb 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 Xian'guo Wang (+8613562898761, wangxianguo1111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in estimated glomerular filtration rate (eGFR) from baseline at the end of the 4th week of treatmentDetailed (time frame: From the start of maintenance treatment with hydromorphinone sustained-release tablets until the end of the fourth week of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07421674, which also lists 18 linked publications.
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 25 Feb 2026.