Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

Study Overview
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Brief Summary
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The aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue

Detailed Description
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This study adopted a randomized controlled design, 2-arm trial cross-over study. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-09). Patients were recruited from the hematology oncology department of Taichung Tzu Chi general hospital. After random assignment to 2 groups, patients in the RS and SR groups will receive real and shame laser acupuncture. Before laser acupuncture, one week later, we will evaluate the patient-reported cancer-related fatigue index and other co-morbid symptoms.

Official Title
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Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

Conditions
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Cancer-related Fatigue

Intervention / Treatment
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* Device: laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 18 to 85 years old Patients who signed the informed consent form Patients who have been given a diagnosis of cancer Able to communicate verbally and completely fill the questionnaires Exclusion Criteria: Patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized controlled, double blind, cross-over study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rear laser acupuncture group<br>Patients in the Real laser acupuncture group will receive real laser pen irradiation. | Device: laser acupuncture<br>* This study will use German-made low-level laser pen (Al-Ga-As diode laser, 810nm, NIR, Physiolaser Olympic Basic, RJ laser). The parameters are power of 100mW, frequency of Bahr, apply on acupoint. Well will irradiate each point for 2 J. Each patient will receive this treatment six times for one week.<br>|
| Sham Comparator: Shame laser acupuncture group<br>Patients in the Shame laser acupuncture group will receive shame laser pen irradiation. | Device: laser acupuncture<br>* This study will use German-made low-level laser pen (Al-Ga-As diode laser, 810nm, NIR, Physiolaser Olympic Basic, RJ laser). The parameters are power of 100mW, frequency of Bahr, apply on acupoint. Well will irradiate each point for 2 J. Each patient will receive this treatment six times for one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related fatigue evaluation | ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form | 30 minutes | 
| Cancer-related fatigue Assessment | Brief Fatigue Inventory-Taiwanese (BFI-T) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessments | Functional Assessment of Cancer Therapy-general (FACT-G7) | 15 minutes | 
| Symptoms distress Assessments | Taiwanese Version of the M.D. Anderson symptom Inventory (MDASI-T) | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser acupuncture