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Not yet recruiting NCT07690293

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

No phase Interventional Cancer-related Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sham Patch, Traditional Chinese Medicine Patch.
Who it may be relevant to
Registry conditions: Cancer-related Fatigue. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention [Time frame: Baseline and approximately 2 weeks]
Secondary outcome measures (4)
  • 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]
  • Change in Heart Rate Variability From Baseline to End of Intervention [Time frame: Baseline and approximately 2 weeks]
  • Change in Complete Blood Count Parameters From Baseline to End of Intervention [Time frame: Baseline and approximately 2 weeks]
  • Incidence of Skin Reactions at the Patch Application Site [Time frame: During the 2-week intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07690293 · CMUH115-REC1-112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗