Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain

Early Phase 1RecruitingNCT07489625

Qinghai Red Cross Hospital30 enrolled

Overview

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.

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 6.0 (CTCAE 6.0).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Hydromorphone Hydrochloride Extended-Release TabletsDRUG

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.

ElectroacupuncturePROCEDURE

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 BeansPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who meet the diagnostic criteria for cancer ; 2. Diagnosis of refractory cancer pain; 3. Aged 18 or 80 years; 4. Expected survival period ≥3 months; 5. Karnofsky Performance Status (KPS) score ≥30 and Quality of Life (QOL) score ≥20; 6. No history of allergy to opioid analgesics; 7. No intellectual or psychiatric disorders; normal comprehension ability,capable of cooperating with pain assessments and questionnaire completion; 8. Provision of signed written informed consent. Exclusion Criteria: 1. Patients with pain clearly unrelated to the tumor itself; 2. Patients with pain relief after standardized pharmacological treatment; 3. Patients aged under 18 years or over 80 years; 4. Patients with an expected survival of less than 3 months; 5. Patients with a Karnofsky Performance Status (KPS) score \< 30 or Quality of Life (QOL) score \< 20; 6. Pregnant or lactating women; 7. Patients with intellectual disability, mental or consciousness disturbance, who are unable to assess pain accurately or complete questionnaire surveys; 8. Patients with needle phobia or extreme resistance to acupuncture treatment; 9. Patients with hypersensitivity to Semen Vaccariae (Wang Bu Liu Xing).

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks

Secondary Outcomes

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

The initial dose will be the equivalent dose of hydromorphone hydrochloride sustained-release tablets converted from the total opioid dose administered in the previous 24 hours. The dose will be titrated upward or downward according to daily baseline pain intensity, frequency of breakthrough pain, and occurrence of adverse reactions.

Time frame: 2 weeks

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

Breakthrough cancer pain (BTcP) is defined as a transient exacerbation of pain that occurs suddenly while baseline cancer pain is relatively well controlled, either spontaneously or induced by specific triggers.The daily frequency of breakthrough cancer pain (BTcP) episodes will be observed in patients during the treatment period.

Time frame: 2 weeks

Adverse Drug Reactions

This study will evaluate the incidence and severity of adverse reactions associated with hydromorphone hydrochloride sustained-release tablets during the treatment period.Adverse events will be graded in accordance with the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0).

Time frame: 2 weeks

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

Assessment using the European Quality of Life 5-Dimensions (EQ-5D) questionnaire.The EQ-5D is a standardized health-related quality of life instrument consisting of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.Each dimension has 3 response levels to describe the patient's functional status or health state.In addition, the EQ-5D includes a visual analogue scale (EQ-VAS) where patients rate their overall health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time frame: 2 weeks

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

This study will evaluate the incidence, severity of adverse reactions related to electroacupuncture and auricular point pressing therapy, as well as treatment compliance during the treatment period. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Time frame: 2 weeks

Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes