NCT04947969

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Cancer-related Fatigue

Keywords

Laser acupuncture

Outcome Measures

Primary Outcomes (2)

  • Cancer-related fatigue evaluation

    ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form

    30 minutes

  • Cancer-related fatigue Assessment

    Brief Fatigue Inventory-Taiwanese (BFI-T)

    15 minutes

Secondary Outcomes (2)

  • Quality of Life Assessments

    15 minutes

  • Symptoms distress Assessments

    20 minutes

Study Arms (2)

Rear laser acupuncture group

EXPERIMENTAL

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

Device: laser acupuncture

Shame laser acupuncture group

SHAM COMPARATOR

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

Device: laser acupuncture

Interventions

laser acupunctureDEVICE

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.

Rear laser acupuncture groupShame laser acupuncture group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Wu Chung Hung, Dr.

CONTACT

886-911856726wuchunghung1@gmail.com

Wu Chung Hung

CONTACT

886-911856726wuchunghung1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized controlled, double blind, cross-over study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chinese medicine department

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 1, 2021

Study Start

July 1, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2023

Last Updated

July 1, 2021

Record last verified: 2021-06