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

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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Key information

Conditions

Cancer-related Fatigue

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

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.

Primary outcomes

Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention

Time frame: Baseline and approximately 2 weeks

Secondary outcomes

Change in Quality of Life Assessed by Functional Assessment of Cancer Therapy-General From Baseline to End of Intervention

Time frame: Baseline and approximately 2 weeks

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.
Change in Heart Rate Variability From Baseline to End of Intervention

Time frame: Baseline and approximately 2 weeks

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.
Change in Complete Blood Count Parameters From Baseline to End of Intervention

Time frame: Baseline and approximately 2 weeks

Complete blood count parameters, including white blood cell count, hemoglobin level, and platelet count, will be measured before and after the intervention.
Incidence of Skin Reactions at the Patch Application Site

Time frame: During the 2-week intervention

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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 8, 2026
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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