Traditional Chinese Medicine Patch for Cancer-Related Fatigue During Radiotherapy
2. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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-komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention
Tidsramme: Baseline and approximately 2 weeks
|
Baseline and approximately 2 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Quality of Life Assessed by Functional Assessment of Cancer Therapy-General From Baseline to End of Intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
31. juli 2027
Studiet fullført (Antatt)
31. juli 2027
Datoer for studieregistrering
Først innsendt
2. juli 2026
Først innsendt som oppfylte QC-kriteriene
2. juli 2026
Først lagt ut (Faktiske)
8. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CMUH115-REC1-112
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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