Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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 6.0.

Eligibility

Primary outcome measure(s)

• Comparison of changes in Numerical Rating Scale (NRS) pain score between baseline and post-treatment. — 2 weeks
  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.

Trial sites (1)

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