Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

NCT ID: NCT04947969

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-07-31

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.

Conditions

Cancer-related Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rear laser acupuncture group

Patients in the Real laser acupuncture group will receive real laser pen irradiation.

Group Type: EXPERIMENTAL

laser acupuncture

Intervention Type: DEVICE

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.

Shame laser acupuncture group

Patients in the Shame laser acupuncture group will receive shame laser pen irradiation.

Group Type: SHAM_COMPARATOR

laser acupuncture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Tzu Chi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wu Chung Hung

Chinese medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wu Chung Hung, Dr.

Role: CONTACT

wuchunghung1@gmail.com

886-911856726

Wu Chung Hung

Role: CONTACT

wuchunghung1@gmail.com

886-911856726

Other Identifiers

REC110-09

Identifier Type: -

Identifier Source: org_study_id