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
23 juli 2026 uppdaterad av: China Medical University Hospital
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention
Tidsram: Baseline and approximately 2 weeks
|
Baseline and approximately 2 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Quality of Life Assessed by Functional Assessment of Cancer Therapy-General From Baseline to End of Intervention
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
31 juli 2027
Avslutad studie (Beräknad)
31 juli 2027
Studieregistreringsdatum
Först inskickad
2 juli 2026
Först inskickad som uppfyllde QC-kriterierna
2 juli 2026
Första postat (Faktisk)
8 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CMUH115-REC1-112
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