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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Chinese Medicine Patch | Experimental | Participants in this arm will receive traditional Chinese medicine patch application at the Shenque (RN8) acupoint once daily for 2 hours, 7 days per week, for 2 consecutive weeks, for a total of 14 sessions. |
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| Sham Patch | Sham Comparator | Participants in this arm will receive a sham patch at the Shenque (RN8) acupoint using the same frequency and duration as the experimental group. The sham patch will be made with flour and caramel coloring instead of traditional Chinese medicine powder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Patch | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention | Baseline and approximately 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Assessed by Functional Assessment of Cancer Therapy-General From Baseline to End of Intervention | Quality of life will be assessed using the Functional Assessment of Cancer Therapy-General questionnaire. The change in total score from baseline to the end of the 2-week intervention will be evaluated. | Baseline and approximately 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Traditional Chinese Medicine Patch | Other | 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. |
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| Change in Heart Rate Variability From Baseline to End of Intervention | Heart rate variability will be measured using a heart rate sensor or wearable device under resting conditions. Changes in heart rate variability parameters from baseline to the end of the 2-week intervention will be evaluated. | Baseline and approximately 2 weeks |
| Change in Complete Blood Count Parameters From Baseline to End of Intervention | Complete blood count parameters, including white blood cell count, hemoglobin level, and platelet count, will be measured before and after the intervention. | Baseline and approximately 2 weeks |
| Incidence of Skin Reactions at the Patch Application Site | Skin reactions at the patch application site will be assessed using the Radiation Therapy Oncology Group skin toxicity grading scale. The intervention will be discontinued if a skin reaction of Grade 2 or higher occurs. | During the 2-week intervention |