Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

June 29, 2021 updated by: Wu Chung Hung, Taichung Tzu Chi Hospital
The aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Tzu Chi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2021

Primary Completion (ANTICIPATED)

July 31, 2022

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (ACTUAL)

July 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC110-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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