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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Qinghai Red Cross Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, single-arm clinical trial designed to address the therapeutic challenge of refractory cancer pain (RCP). It will systematically explore the synergistic therapeutic effect of hydromorphone hydrochloride sustained-release tablets (HHST) combined with electroacupuncture (EA) and ear acupoint pressing beans (EAPB). Through a clinical research design, the study will comprehensively evaluate the efficacy and safety of this combined regimen in relieving RCP. The primary observational focus of the study will be the dynamic changes in the Numerical Rating Scale (NRS) scores of patients before and after treatment. Researchers will quantitatively analyze the proportion of patients achieving effective analgesia (defined as a ≥30% reduction in NRS score from baseline) and marked remission (defined as a ≥50% reduction in NRS score from baseline). Meanwhile, the study will monitor key indicators to verify the analgesic efficacy and safety of the combined regimen from multiple dimensions: the daily dosage of HHST, the frequency of breakthrough pain (BP) episodes, and drug-related adverse events (AEs). All AEs will be graded in accordance with the Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0).

Conditions

• Refractory Cancer Pain
• Cancer Pain

Interventions

Type	Name	Description
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.
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.
PROCEDURE	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.

Timeline

• Start date: 2026-03-07
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: China