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

Официальное название

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

Обзор

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

Вмешательства

• Препарат 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.

Первичные конечные точки

• 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. [Срок оценки: From baseline to Day 14]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Uni — Пекин

Идентификаторы

NCT: NCT07657390 · 25/649-5595

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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