Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorTaian Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years.
Pathologically or cytologically confirmed malignant tumor.
Opioid-naïve patients with moderate-to-severe cancer pain (Numerical Rating Scale score ≥ 4).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
62 Participants
are grouped into 2 trial groupsGroup A: Hydromorphone - Renal Insufficiency Group
Group B: Hydromorphone - Normal Renal Function Group
Trial outcomes
Primary outcomes
1
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.
Time frame
From the start of maintenance treatment with hydromorphinone sustained-release tablets until the end of the fourth week of treatment.Sponsors and contacts
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Source ClinicalTrials.gov
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