Prospective Randomized Controlled Clinical Study of Acupoint Application With Gutong Plaster in t… (NCT07657390) | Clinical Trial Compass
RecruitingPhase 1/2
Prospective Randomized Controlled Clinical Study of Acupoint Application With Gutong Plaster in the Treatment of Moderate to Severe Cancer Pain
China198 participantsStarted 2025-12-25
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1/2, which means it's still in early stages — what does that mean for how much we know about whether the Gutong Plaster acupoint treatment is safe and effective for cancer pain at my level?
2The trial is measuring 'response rate' based on whether pain scores drop by 50% or more — given where my pain currently is on a scale, does my doctor think I would realistically be able to tell if that kind of improvement was happening?
3Since this study uses acupoint application, which is a traditional Chinese medicine approach applied to the skin, are there any concerns about interactions with my current pain medications or cancer treatments that I should be aware of?
4Before considering a trial like this, should I first try or complete standard pain management options for moderate to severe cancer pain, and how does this trial fit alongside or after those options?
5This trial is actively recruiting right now — what would participating actually look like in terms of clinic visits, how the plaster is applied, and whether I would still have access to my usual pain relief if the treatment isn't working well enough?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: From baseline to Day 14
Trial details
NCT IDNCT07657390
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. 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.