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Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain
Sponsor: Qinghai Red Cross Hospital
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-03-07
Completion Date
2028-12-31
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Locations (1)
Qinghai Red Cross Hospital
Xining, China