Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain

NCT07489625 | Not Yet Recruiting Early Phase 1

• 1 other identifier: KY-2025-181
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Cancer Pain; Cancer Pain

Keywords

electroacupuncture; ear acupoint pressing beans; hydromorphone; refractory cancer pain; cancer pain

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 weeks

Secondary Outcomes (5)

• Comparison of the change in dosage of hydromorphone hydrochloride extended-release tablets during treatment.

  2 weeks

• Comparison of the daily frequency of breakthrough pain between baseline and post-treatment.

  2 weeks

• Adverse Drug Reactions

  2 weeks

• Comparison of changes in health-related quality of life from baseline to post-treatment.

  2 weeks

• Incidence of Adverse Reactions Associated with Electroacupuncture and Ear Acupoint Pressing Beans

  2 weeks

Study Arms (1)

Combined Therapy Group

EXPERIMENTAL

Drug: Hydromorphone Hydrochloride Extended-Release Tablets; Procedure: Electroacupuncture; Procedure: Ear Acupoint Pressing Beans

Interventions

Ear Acupoint Pressing Beans PROCEDURE

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.

Combined Therapy Group

Hydromorphone Hydrochloride Extended-Release Tablets DRUG

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.

Combined Therapy Group

Electroacupuncture PROCEDURE

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.

Combined Therapy Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the diagnostic criteria for cancer ;
• Diagnosis of refractory cancer pain;
• Aged 19 or 80 years;
• Expected survival period ≥3 months;
• Karnofsky Performance Status (KPS) score ≥30 and Quality of Life (QOL) score ≥20;
• No history of allergy to opioid analgesics;
• No intellectual or psychiatric disorders; normal comprehension ability,capable of cooperating with pain assessments and questionnaire completion;
• Provision of signed written informed consent.

You may not qualify if:

• Patients with pain clearly unrelated to the tumor itself;
• Patients with pain relief after standardized pharmacological treatment;
• Patients aged under 19 years or over 80 years;
• Patients with an expected survival of less than 3 months;
• Patients with a Karnofsky Performance Status (KPS) score \< 30 or Quality of Life (QOL) score \< 20;
• Pregnant or lactating women;
• Patients with intellectual disability, mental or consciousness disturbance, who are unable to assess pain accurately or complete questionnaire surveys;
• Patients with needle phobia or extreme resistance to acupuncture treatment;
• Patients with hypersensitivity to Semen Vaccariae (Wang Bu Liu Xing).

Sponsors & Collaborators

• Qinghai Red Cross Hospital: lead

Study Sites (1)

Qinghai Red Cross Hospital

Xining, China

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: March 7, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-01

Locations

CN (1)