Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

Not Applicable

• Conditions: Cancer-related Fatigue
• Interventions: Device: laser acupuncture

• Registration Number: NCT04947969
• Lead Sponsor: Taichung Tzu Chi Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study Start: 2021-07-01
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01
• Primary Completion: 2022-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rear laser acupuncture group	laser acupuncture	Patients in the Real laser acupuncture group will receive real laser pen irradiation.
Shame laser acupuncture group	laser acupuncture	Patients in the Shame laser acupuncture group will receive shame laser pen irradiation.

Primary Outcome Measures

Name	Time	Method
Cancer-related fatigue evaluation	30 minutes	ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form
Cancer-related fatigue Assessment	15 minutes	Brief Fatigue Inventory-Taiwanese (BFI-T)

Secondary Outcome Measures

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