Efficacy of Traditional Chinese Medicine Patch Application at the Shenque (RN8) Acupoint in Cancer Patients Scheduled to Undergo Radiotherapy: A Study on Cancer-Related Fatigue and Heart Rate Variability

Обзор

This randomized, double-blind, parallel-group controlled clinical trial aims to evaluate the effects of traditional Chinese medicine patch application at the Shenque (RN8) acupoint on cancer-related fatigue in adult cancer patients scheduled to undergo radiotherapy. Eligible participants will be randomly assigned to receive either a traditional Chinese medicine patch or a sham patch at the same acupoint. The intervention will be applied once daily for 2 hours, 7 days per week, for 2 consecutive weeks, for a total of 14 sessions. Fatigue severity, quality of life, heart rate variability, complete blood count, and skin safety will be assessed before and after the intervention.

Вмешательства

• Другое Sham Patch
  The sham patch will be applied at the Shenque (RN8) acupoint using the same frequency and duration as the experimental intervention. The sham patch will be made with 5 g of flour and caramel coloring instead of traditional Chinese medicine powder.
• Другое Traditional Chinese Medicine Patch
  The traditional Chinese medicine patch will be applied at the Shenque (RN8) acupoint once daily for 2 hours, 7 days per week, for 2 consecutive weeks, for a total of 14 sessions. The patch will be prepared by mixing 5 g of traditional Chinese medicine powder with 7 g of water and applying the mixture to gauze or a patch.

Первичные конечные точки

• Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention [Срок оценки: Baseline and approximately 2 weeks]

Вторичные конечные точки (4)

• Change in Quality of Life Assessed by Functional Assessment of Cancer Therapy-General From Baseline to End of Intervention [Срок оценки: Baseline and approximately 2 weeks]
• Change in Heart Rate Variability From Baseline to End of Intervention [Срок оценки: Baseline and approximately 2 weeks]
• Change in Complete Blood Count Parameters From Baseline to End of Intervention [Срок оценки: Baseline and approximately 2 weeks]
• Incidence of Skin Reactions at the Patch Application Site [Срок оценки: During the 2-week intervention]

Критерии участия

Критерии включения

• Adults aged 20 years or older.
• Patients diagnosed with cancer by a physician.
• Patients scheduled to undergo radiotherapy.
• Patients who meet the diagnostic criteria for cancer-related fatigue and have a fatigue scale score of 4 or higher.
• Patients who are willing and able to provide written informed consent after receiving an explanation of the study procedures and possible risks.

Критерии исключения

• Patients who are not suitable for traditional Chinese medicine patch application, including those with wounds or skin lesions at the acupoint application site.
• Patients who are unwilling to sign the informed consent form.
• Minors, pregnant women, patients with psychiatric disorders, or vulnerable populations.
• Patients with diseases that may affect heart rate variability.
• Patients who have received astragalus polysaccharide injection within 1 month before the start of the study.
• Patients who have used Chinese herbal medicine within 1 month before the start of the study.

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

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07690293 · CMUH115-REC1-112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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