Traditional Chinese Medicine Patch for Cancer-Related Fatigue During Radiotherapy

July 2, 2026 updated by: China Medical University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Traditional Chinese Medicine Patch
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
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.
Sham Comparator: Sham Patch
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention
Time Frame: Baseline and approximately 2 weeks
Baseline and approximately 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and approximately 2 weeks
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.
Baseline and approximately 2 weeks
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.
Baseline and approximately 2 weeks
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.
During the 2-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMUH115-REC1-112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer-related Fatigue

Clinical Trials on Traditional Chinese Medicine Patch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings