Cancer-related FatigueNCT07690293
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
A study testing Traditional Chinese Medicine Patch in people with Cancer-related Fatigue, run by China Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Traditional Chinese Medicine Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Sham Patch, Traditional Chinese Medicine Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham PatchOther
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 PatchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention
Measured: 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
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.
Measured: Baseline and approximately 2 weeks
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.
Measured: 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.
Measured: 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.
Measured: During the 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690293
- Sponsor's protocol ID
- CMUH115-REC1-112
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07690293
- Acronym / sponsor ID
- CMUH115-REC1-112
- Conditions
- Cancer-related Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine Patch | Experimental | Other: Traditional Chinese Medicine PatchParticipants 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. |
| Sham Patch | Sham comparator | Other: Sham PatchParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham PatchThe 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 | Sham Patch |
| Traditional Chinese Medicine PatchThe 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. | Other | Traditional Chinese Medicine Patch |
Primary outcome
Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention
Time frame: Baseline and approximately 2 weeks
4 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine Patch in people with Cancer-related Fatigue, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention (time frame: Baseline and approximately 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.