Clinical trial · Interventional
Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain
Observation on the Clinical Efficacy of Hydromorphone Hydrochloride Sustained-Release Tablets Combined With Electroacupuncture and Ear Acupoint Pressing Beans in the Treatment of Refractory Cancer Pain
- 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 trial aims to address refractory cancer pain (RCP). It will explore the synergistic efficacy and safety of hydromorphone hydrochloride sustained-release tablets (HHST) combined with electroacupuncture (EA) and ear acupoint pressing beans (EAPB) for RCP. Key outcomes will include dynamic changes in Numerical Rating Scale (NRS) scores, proportions of patients with effective analgesia (≥30% NRS reduction from baseline) and marked remission (≥50% NRS reduction from baseline), daily HHST dosage, breakthrough pain (BP) frequency, and drug-related adverse events (AEs) graded by CTCAE 6.0.
Conditions
Conditions (2)
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 | — |
| Refractory Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ear Acupoint Pressing Beans | Procedure | — | UNRESOLVED |
| Electroacupuncture | Procedure | — | UNRESOLVED |
| Hydromorphone Hydrochloride Extended-Release Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined Therapy Group
- interventionNames
- Drug: Hydromorphone Hydrochloride Extended-Release Tablets
- Procedure: Electroacupuncture
- Procedure: Ear Acupoint Pressing Beans
Primary outcomes (1)
- measure
- Comparison of changes in Numerical Rating Scale (NRS) pain score between baseline and post-treatment.
- timeFrame
- 2 weeks
- description
- Pain intensity will be measured by the Numerical Rating Scale (0-10).Primary endpoints:(1) Analgesic efficacy rate: proportion of patients with ≥30% reduction in NRS from baseline;(2) Significant relief rate: proportion with ≥50% reduction in NRS from baseline.Assessments will be conducted at baseline and at the end of the 2-week treatment.
Secondary outcomes (5)
- measure
- Comparison of the change in dosage of hydromorphone hydrochloride extended-release tablets during treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who meet the diagnostic criteria for cancer ; 2. Diagnosis of refractory cancer pain; 3. Aged 18 or 80 years; 4. Expected survival period ≥3 months; 5. Karnofsky Performance Status (KPS) score ≥30 and Quality of Life (QOL) score ≥20; 6. No history of allergy to opioid analgesics; 7. No intellectual or psychiatric disorders; normal comprehension ability,capable of cooperating with pain assessments and questionnaire completion; 8. Provision of signed written informed consent. Exclusion Criteria: 1. Patients with pain clearly unrelated to the tumor itself; 2. Patients with pain relief after standardized pharmacological treatment; 3. Patients aged under 18 years or over 80 years; 4. Patients with an expected survival of less than 3 months; 5. Patients with a Karnofsky Performance Status (KPS) score \< 30 or Quality of Life (QOL) score \< 20; 6. Pregnant or lactating women; 7. Patients with intellectual disability, mental or consciousness disturbance, who are unable to assess pain accurately or complete questionnaire surveys; 8. Patients with needle phobia or extreme resistance to acupuncture treatment; 9. Patients with hypersensitivity to Semen Vaccariae (Wang Bu Liu Xing).
References
Publications (0)
Data not yet available