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

NCT07690293 | Not Yet Recruiting

• 1 other identifier: CMUH115-REC1-112
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (1)

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

  Baseline and approximately 2 weeks

Secondary Outcomes (4)

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

  Baseline and approximately 2 weeks

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

  Baseline and approximately 2 weeks

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

  Baseline and approximately 2 weeks

• Incidence of Skin Reactions at the Patch Application Site

  During the 2-week intervention

Study Arms (2)

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.

Other: Traditional Chinese Medicine Patch

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.

Other: Sham Patch

Interventions

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.

Sham Patch

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.

Traditional Chinese Medicine Patch

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07