Clinical trial · Observational
Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency
Application Research of Hydromorphinone Sustained-release Tablets in the Treatment of Elderly Patients With Cancer Pain Accompanied by Renal Insufficiency
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
| Hydromorphone Use | — | UNRESOLVED | — |
| Renal Insufficiency Chronic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Hydromorphone - Renal Insufficiency Group
- description
- 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.
- label
- Hydromorphone - Normal Renal Function Group
- description
- 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.
Primary outcomes (1)
- measure
- The changes in estimated glomerular filtration rate (eGFR) from baseline at the end of the 4th week of treatmentDetailed
- timeFrame
- From the start of maintenance treatment with hydromorphinone sustained-release tablets until the end of the fourth week of treatment.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 65 years. 2. Pathologically or cytologically confirmed malignant tumor. 3. Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4). 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. Exclusion Criteria: 1. Severe renal insufficiency (eGFR \< 30 mL/min/1.73m²) or requirement for renal replacement therapy. 2. Severe hepatic insufficiency (alanine aminotransferase / aspartate aminotransferase ≥ 2.5 times the upper limit of normal or Child-Pugh Class C). 3. Paralytic ileus. 4. Pain of unclear origin or pain that is solely acute/incident pain. 5. Symptoms or history of diseases such as intracranial hypertension, head injury, cerebral aneurysm, or other central nervous system disorders. 6. Symptoms of prostatic hypertrophy, thyroid dysfunction, or urethral stricture. Symptoms of asthma, respiratory obstruction, or respiratory failure. 7. Known allergy or hypersensitivity to hydromorphone or oxycodone. 8. Use of monoamine oxidase inhibitors within 14 days prior to enrollment. 9. Participation in any other clinical trial within 1 month prior to enrollment. 10. Any other condition considered by the investigator as unsuitable for participation in this study.
References
Publications (18)
- BACKGROUNDZheng 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. PMID 39554558
- BACKGROUNDLin 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. PMID 34343968
- BACKGROUNDHanna 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. PMID 18976472
- BACKGROUNDvan 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. PMID 22765848
- BACKGROUNDKullgren 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. PMID 23930920
- BACKGROUNDCarter 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. PMID 20297858
- BACKGROUNDOdoma 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.