Cancer-related Fatigue
Conditions
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.
Interventions
OTHERSham 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.
OTHERTraditional 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.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention | Baseline and approximately 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Assessed by Functional Assessment of Cancer Therapy-General From Baseline to End of Intervention | 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 | 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 | 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 | 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. |
Outcome results
None listed