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

June 14, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Prospective Randomized Controlled Clinical Trial of Acupoint Application With Gutong Plaster for 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100700
        • Recruiting
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
The experimental group received Gutong Plaster treatment. Herbal raw materials were supplied by the Pharmacy of Cancer Hospital, Chinese Academy of Medical Sciences, and processed into powder at the South District of Sihui Hospital. The powder was crushed, sieved and packaged in 10-gram sachets.
Drug: On the basis of conventional analgesia, patients receive treatment with Gutong Plaster.
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.
Placebo Comparator: placabo
The placebo group was treated with Gutong Plaster placebo.The matching placebo for the Gutong Plaster is composed of 1/20 of the Gutong Plaster's raw materials plus yellow corn flour, and its preparation method refers to The Preparation Technology of Placebo for External Chinese Medicine Powders. All study medications are uniformly prepared, numbered, and distributed by the research team, and stored at room temperature in a dry environment.
Drug: On the basis of conventional analgesia, patients receive treatment with Gutong Plaster.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From baseline to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

June 14, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/649-5595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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