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

N/ANot Yet RecruitingNCT07690293

China Medical University Hospital80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Cancer-related Fatigue

Interventions

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention

Time frame: Baseline and approximately 2 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: During the 2-week intervention