Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

Sponsor

Taichung Tzu Chi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04947969

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer-related Fatigue	Device: laser acupuncture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized controlled, double blind, cross-over study.Randomized controlled, double blind, cross-over study.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

After random assignment to 2 groups, patients in the RS and SR groups will receive real and shame laser acupuncture (single blinding), six consecutive times every day.

Primary Purpose:

Treatment

Official Title:

Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rear laser acupuncture group Patients in the Real laser acupuncture group will receive real laser pen irradiation.	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.
Sham Comparator: Shame laser acupuncture group Patients in the Shame laser acupuncture group will receive shame laser pen irradiation.	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.

Arm

Intervention/Treatment

Experimental: Rear laser acupuncture group

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

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.

Sham Comparator: Shame laser acupuncture group

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

Device: laser acupuncture

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taichung Tzu Chi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wu Chung Hung, Chinese medicine department, Taichung Tzu Chi Hospital

ClinicalTrials.gov Identifier:

NCT04947969

Other Study ID Numbers:

REC110-09

First Posted:

Jul 1, 2021

Last Update Posted:

Jul 1, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wu Chung Hung, Chinese medicine department, Taichung Tzu Chi Hospital

Laser acupuncture

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Jul 1, 2021