Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

Cancer-related Fatigue Clinical Trial

Official title:

Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04947969
• Other study ID #: REC110-09
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: June 2021
• Source: Taichung Tzu Chi Hospital
• Contact: Wu Chung Hung, Dr.
• Phone: 886-911856726
• Email: wuchunghung1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

Device:
• laser acupuncture
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Tzu Chi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-related fatigue evaluation	ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form	30 minutes
Primary	Cancer-related fatigue Assessment	Brief Fatigue Inventory-Taiwanese (BFI-T)	15 minutes
Secondary	Quality of Life Assessments	Functional Assessment of Cancer Therapy-general (FACT-G7)	15 minutes
Secondary	Symptoms distress Assessments	Taiwanese Version of the M.D. Anderson symptom Inventory (MDASI-T)	20 minutes