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NCT Number: NCT07657390

Prospective Randomized Controlled Clinical Study of Acupoint Application With Gutong Plaster in the Treatment of Moderate to Severe Cancer Pain

This clinical trial aims to evaluate the efficacy and safety of acupoint application with Gutong Plaster for treating moderate to severe cancer pain in patients aged ≥18 years with moderate to severe cancer pain (NRS 4-8), ECOG 0-3, life expectancy ≥3 months. The main questions it aims to answer are:

Does acupoint application with Gutong Plaster improve the response rate (CR + PR) in patients with moderate to severe cancer pain? Does Gutong Plaster reduce pain intensity (NRS score) and opioid consumption in cancer pain patients? Researchers will compare patients receiving oxycodone plus Gutong Plaster to patients receiving oxycodone plus placebo simulant to see if Gutong Plaster provides better pain relief and lower opioid use.

Participants will:

Receive standard treatment with oxycodone prolonged-release tablets Be randomly assigned to receive Gutong Plaster or placebo simulant via acupoint application twice daily for 14 days Undergo pain assessment, quality of life evaluation, safety laboratory tests, and follow-up at specified time points

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100700, China

Location status: Recruiting

Location contact

Jinyuan Chang

CONTACT

[email protected]

86+13261804346

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known allergy to any active ingredient or excipient of the study drug, or a history of allergy to other opioids and their related components.
  • Persistent pain caused by other diseases or unknown causes.
  • Subjects presenting with urgent symptoms such as intestinal obstruction/perforation, spinal cord compression, or pathological fracture.
  • History of severe psychiatric disorders, such as schizophrenia and depression.
  • 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).
  • 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.
  • Other conditions deemed unsuitable for participation in this study by the investigator, such as poor compliance.

Treatment and study plan

On the basis of conventional analgesia, patients receive treatment with Gutong Plaster.

Drug

When in use, the Gutong Plaster powder is evenly mixed with petrolatum at a ratio of 2:1, then spread uniformly on medical breathable adhesive plasters (blank three-volt patch bases). The patches are applied to the following acupoints: Tianshu (ST25) and Guanyuan (CV4) for warming yang and tonifying qi; Fenglong (ST40), Xuehai (SP10), and Sanyinjiao (SP6) for removing blood stasis and detoxification.

Primary outcomes

  1. Response rate : Defined as the sum of the complete response (CR) rate plus the partial response (PR) rate. Partial response is defined as a reduction of 50% or more in the pain score from baseline to post-treatment.

    Time frame: From baseline to Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Jinyuan Chang

CONTACT

[email protected]

86+13261804346

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Prospective Randomized Controlled Clinical Trial of Acupoint Application With Gutong Plaster for Moderate to Severe Cancer Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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