Hydromorphone plus electroacupuncture and ear acupressure for refractory cancer pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a early-phase, single-arm clinical trial evaluating a combined regimen of hydromorphone hydrochloride extended-release tablets with electroacupuncture and ear acupoint pressing beans for patients with refractory cancer pain. The study will track changes in pain scores, the proportion of patients achieving at least 30% and 50% reductions in pain, daily opioid dose, breakthrough pain frequency, and adverse events using standard CTCAE 6.0 criteria. Patients will be monitored for safety and pain relief over the course of treatment to determine the regimen's potential efficacy and tolerability. The trial focuses on patients with limited response to standard therapies and aims to establish preliminary signals of benefit for this multimodal approach.

Why it matters

Who can join: the full rules

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).

Where it's running

• Qinghai Red Cross Hospital
  Xining, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.