Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
Primary Purpose
Cancer-related Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Cancer-related Fatigue focused on measuring Laser acupuncture
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Rear laser acupuncture group
Shame laser acupuncture group
Arm Description
Patients in the Real laser acupuncture group will receive real laser pen irradiation.
Patients in the Shame laser acupuncture group will receive shame laser pen irradiation.
Outcomes
Primary Outcome Measures
Cancer-related fatigue evaluation
ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form
Cancer-related fatigue Assessment
Brief Fatigue Inventory-Taiwanese (BFI-T)
Secondary Outcome Measures
Quality of Life Assessments
Functional Assessment of Cancer Therapy-general (FACT-G7)
Symptoms distress Assessments
Taiwanese Version of the M.D. Anderson symptom Inventory (MDASI-T)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04947969
Brief Title
Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
Official Title
Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Tzu Chi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue
Keywords
Laser acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled, double blind, cross-over study.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rear laser acupuncture group
Arm Type
Experimental
Arm Description
Patients in the Real laser acupuncture group will receive real laser pen irradiation.
Arm Title
Shame laser acupuncture group
Arm Type
Sham Comparator
Arm Description
Patients in the Shame laser acupuncture group will receive shame laser pen irradiation.
Intervention Type
Device
Intervention Name(s)
laser acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cancer-related fatigue evaluation
Description
ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form
Time Frame
30 minutes
Title
Cancer-related fatigue Assessment
Description
Brief Fatigue Inventory-Taiwanese (BFI-T)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Quality of Life Assessments
Description
Functional Assessment of Cancer Therapy-general (FACT-G7)
Time Frame
15 minutes
Title
Symptoms distress Assessments
Description
Taiwanese Version of the M.D. Anderson symptom Inventory (MDASI-T)
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Chung Hung, Dr.
Phone
886-911856726
Email
wuchunghung1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Chung Hung
Phone
886-911856726
Email
wuchunghung1@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
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