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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
Taichung Tzu Chi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Fatigue focused on measuring Laser acupuncture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    June 29, 2021
    Last Updated
    June 29, 2021
    Sponsor
    Taichung Tzu Chi Hospital
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    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

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    Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue

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