[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630588":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":11,"locations":31,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Qinghai Red Cross Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined Therapy Group","EXPERIMENTAL",null,[13,14,15],"Drug: Hydromorphone Hydrochloride Extended-Release Tablets","Procedure: Electroacupuncture","Procedure: Ear Acupoint Pressing Beans",[17,22,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","Hydromorphone Hydrochloride Extended-Release Tablets","Extended-release hydromorphone hydrochloride tablets will be initiated at a dose converted from the total 24-hour opioid dose before treatment, rounded down to the nearest whole tablet, and administered orally once daily.Patients will be evaluated every 24 hours, and the dosage will be adjusted according to changes in pain intensity and Numerical Rating Scale (NRS) score.The dose will be maintained if the daily baseline pain NRS score is ≤3 and breakthrough pain occurs ≤2 times per day.If the daily baseline pain NRS score is \\>3 or breakthrough pain occurs \\>2 times per day, the dose may be titrated upward or downward based on adverse reactions. The dose will be titrated upward with an increment of 8 mg, and the interval between dose titrations shall be at least 2 days.",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"PROCEDURE","Electroacupuncture","Electroacupuncture will be performed at three specific points: Zusanli (ST36), Quchi (LI11), and Kunlun (BL60). Following needle insertion and deqi sensation, electrodes will be connected to an electroacupuncture device delivering 2Hz dense-disperse wave stimulation for 30 minutes. One treatment cycle lasts 7 days, and treatment will be administered once daily for a total of 14 days.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Ear Acupoint Pressing Beans","Six auricular acupoints will be selected, including Shenmen, Subcortex, Sympathetic, Endocrine, Liver, and Kidney. Vaccaria seeds will be attached to these acupoints and gently pressed with fingers until the patient experiences a sensation of soreness and distension. For continuous stimulation, pressing will be performed 3-5 times daily, 1-2 minutes each time, for a duration of 3-5 days.",[9],[32],{"facility":5,"status":11,"city":33,"state":11,"zip":11,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Xining","China","CN",{"type":37,"coordinates":38},"Point",[39,40],101.75739,36.62554,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Qiuxia Dong","CONTACT","0971-8267613","2816278916@qq.com",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100630588","early-phase-1-hydromorphone-with-electroacupuncture-and-ear-acupoint-pressing-for-refractory-cancer-pain-100630588",false,"NCT07489625","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","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for cancer ;\n2. Diagnosis of refractory cancer pain;\n3. Aged 19 or 80 years;\n4. Expected survival period ≥3 months;\n5. Karnofsky Performance Status (KPS) score ≥30 and Quality of Life (QOL) score ≥20;\n6. No history of allergy to opioid analgesics;\n7. No intellectual or psychiatric disorders; normal comprehension ability,capable of cooperating with pain assessments and questionnaire completion;\n8. Provision of signed written informed consent.\n\nExclusion Criteria:\n\n1. Patients with pain clearly unrelated to the tumor itself;\n2. Patients with pain relief after standardized pharmacological treatment;\n3. Patients aged under 19 years or over 80 years;\n4. Patients with an expected survival of less than 3 months;\n5. Patients with a Karnofsky Performance Status (KPS) score \\\u003C 30 or Quality of Life (QOL) score \\\u003C 20;\n6. Pregnant or lactating women;\n7. Patients with intellectual disability, mental or consciousness disturbance, who are unable to assess pain accurately or complete questionnaire surveys;\n8. Patients with needle phobia or extreme resistance to acupuncture treatment;\n9. Patients with hypersensitivity to Semen Vaccariae (Wang Bu Liu Xing).","ALL","19 Years","80 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"EARLY_PHASE1","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 5.0.",[68,69],"Refractory Cancer Pain","Cancer Pain",[71,72,73,74,75],"electroacupuncture","ear acupoint pressing beans","hydromorphone","refractory cancer pain","cancer pain","NOT_YET_RECRUITING","2026-03-18",{"date":79,"type":80},"2026-03-24","ACTUAL",{"date":82,"type":62},"2026-03-07",{"date":84,"type":62},"2028-12-31",{"name":5,"class":6},1]