Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат 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 da
• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Comparison of changes in Numerical Rating Scale (NRS) pain score between baseline and post-treatment. [Срок оценки: 2 weeks]

Вторичные конечные точки (5)

• Comparison of the change in dosage of hydromorphone hydrochloride extended-release tablets during treatment. [Срок оценки: 2 weeks]
• Comparison of the daily frequency of breakthrough pain between baseline and post-treatment. [Срок оценки: 2 weeks]
• Adverse Drug Reactions [Срок оценки: 2 weeks]
• Comparison of changes in health-related quality of life from baseline to post-treatment. [Срок оценки: 2 weeks]
• Incidence of Adverse Reactions Associated with Electroacupuncture and Ear Acupoint Pressing Beans [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qinghai Red Cross Hospital — Xining

Идентификаторы

NCT: NCT07489625 · KY-2025-181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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