Gutong Plaster at Acupoints for Moderate to Severe 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 interventional trial randomizes adults with moderate to severe cancer pain (NRS 4-8, ECOG 0-3) to receive Gutong Plaster at acupoints or a placebo plaster for 14 days, on top of oxycodone therapy. Participants continue standard analgesia and are assessed for pain relief, opioid consumption, and quality of life. The study aims to see if Gutong Plaster improves response rate (complete or partial), lowers pain scores, and reduces opioid use compared with placebo. It is conducted in Chinese medical centers with a focus on safety and tolerability in conjunction with conventional analgesia. The sponsor is the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, with collaboration at national centers in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The subject has signed the informed consent form.
2. Age ≥ 18 years, including males and females.
3. According to the investigator's assessment, the subject has relatively stable cancer pain and requires continuous analgesic medication (estimated treatment duration ≥ 2 weeks).
4. Estimated life expectancy ≥ 3 months.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.
6. Adequate organ function.
7. Patients with moderate to severe cancer pain, defined as 4 ≤ NRS (Numeric Rating Scale) score ≤ 8.

Exclusion Criteria:

1. Known allergy to any active ingredient or excipient of the study drug, or a history of allergy to other opioids and their related components.
2. Persistent pain caused by other diseases or unknown causes.
3. Subjects presenting with urgent symptoms such as intestinal obstruction/perforation, spinal cord compression, or pathological fracture.
4. History of severe psychiatric disorders, such as schizophrenia and depression.
5. Patients currently receiving chemotherapy or still in the chemotherapy reaction period (patients in the chemotherapy interval may be included. That is, patients who have completed chemotherapy for more than 1 week can be enrolled, or patients who have just finished chemotherapy may be enrolled at the investigator's discretion).
6. Patients who have received radiotherapy to the pain area within 4 weeks before enrollment (those who have received radiotherapy to areas other than the pain area may be included), or those who plan to receive radiotherapy to the pain area during the study.
7. Other conditions deemed unsuitable for participation in this study by the investigator, such as poor compliance.

Where it's running

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jinyuan Chang
• Email: jychangncc@163.com
• Phone: 86+13261804346

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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.