Refractory Cancer PainEarly Phase 1NCT07489625

Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain

A Early Phase 1 study testing Hydromorphone Hydrochloride Extended-Release Tablets, Electroacupuncture and Ear Acupoint Pressing Beans in people with Refractory Cancer Pain and Cancer Pain, run by Qinghai Red Cross Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Refractory Cancer Pain, Cancer Pain
What is being tested?: Hydromorphone Hydrochloride Extended-Release Tablets, Electroacupuncture and Ear Acupoint Pressing Beans
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 5 Aug 2026to 31 Dec 2028
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who meet the diagnostic criteria for cancer ;
Diagnosis of refractory cancer pain;
Aged 18 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.

Who cannot join

Patients with pain clearly unrelated to the tumor itself;
Patients with pain relief after standardized pharmacological treatment;
Patients aged under 18 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;

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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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

Qinghai Red Cross Hospital
Xining
Qiuxia Dong, 0971-8267613, 2816278916@qq.com
Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the 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 6.0 (CTCAE 6.0).

Conditions: Refractory Cancer Pain, Cancer Pain
Being tested: Hydromorphone Hydrochloride Extended-Release Tablets, Electroacupuncture, Ear Acupoint Pressing Beans
Keywords: electroacupuncture, ear acupoint pressing beans, hydromorphone, refractory cancer pain, cancer pain
Medical subject headings: Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 or surgery
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 or surgery
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 groups in NCT07489625
Study group	Role	What they receive
Combined Therapy Group	Experimental	Not described Receives: Drug: Hydromorphone Hydrochloride Extended-Release Tablets; Procedure: Electroacupuncture; Procedure: Ear Acupoint Pressing Beans

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 weeks

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 202631 Dec 2028

First posted24 Mar 2026
Study start5 Aug 2026
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractory Cancer PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07489625
Sponsor's protocol ID: KY-2025-181
Status last verified: Aug 2026
First submitted: 18 Mar 2026
Last updated: 14 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Refractory Cancer Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07489625
Acronym / sponsor ID: KY-2025-181
Conditions: Refractory Cancer Pain, Cancer Pain
Keywords: electroacupuncture, ear acupoint pressing beans, hydromorphone, refractory cancer pain, cancer pain
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Qinghai Red Cross HospitalUniversity, hospital or other
Study start: 5 Aug 2026 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 24 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Combined Therapy Group	Experimental	Drug: Hydromorphone Hydrochloride Extended-Release Tablets, Procedure: Electroacupuncture, Procedure: Ear Acupoint Pressing Beans

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients who meet the diagnostic criteria for cancer ;
Diagnosis of refractory cancer pain;
Aged 18 or 80 years;
Expected survival period ≥3 months;
Karnofsky Performance Status (KPS) score ≥30 and Quality of Life (QOL) score ≥20;

Key exclusion criteria (9 listed)

Patients with pain clearly unrelated to the tumor itself;
Patients with pain relief after standardized pharmacological treatment;
Patients aged under 18 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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydromorphone Hydrochloride Extended-Release TabletsExtended-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.	Drug	Combined Therapy Group
ElectroacupunctureElectroacupuncture 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 or surgery	Combined Therapy Group
Ear Acupoint Pressing BeansSix 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.	Procedure or surgery	Combined Therapy Group

Primary outcome

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

5 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.

Related trials for Refractory Cancer Pain

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Psilocybin in Cancer Pain Study
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RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
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Not yet recruitingObservational study
Lidocaine Infusions for Pain in Patients With Malignant Bowel Obstruction
Malignant Bowel Obstruction, Cancer Pain
Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Qinghai Red Cross Hospital

Xining, China

0971-8267613

2816278916@qq.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of changes in Numerical Rating Scale (NRS) pain score between baseline and post-treatment. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07489625.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.