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Traditional Chinese Medicine Patch for Cancer-Related Fatigue During Radiotherapy

2. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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-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.
Andet: 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.

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

China Medical University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

31. juli 2027

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CMUH115-REC1-112

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Betingelser

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Placeringer

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