Cancer-related FatigueNCT04947969
Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
A study testing laser acupuncture in people with Cancer-related Fatigue, run by Taichung Tzu Chi Hospital.
Trial summary
The aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to examine the clinical effect of laser acupuncture on improving cancer-related fatigue
Read the 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.
- Conditions
- Cancer-related Fatigue
- Being tested
- laser acupuncture
- Keywords
- Laser acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Rear laser acupuncture group | Experimental | Patients in the Real laser acupuncture group will receive real laser pen irradiation. Receives: Device: laser acupuncture |
| Shame laser acupuncture group | Sham comparator | Patients in the Shame laser acupuncture group will receive shame laser pen irradiation. Receives: Device: laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related fatigue evaluation
ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form
Measured: 30 minutes
Cancer-related fatigue Assessment
Brief Fatigue Inventory-Taiwanese (BFI-T)
Measured: 15 minutes
Secondary outcomes (2)
Quality of Life Assessments
Functional Assessment of Cancer Therapy-general (FACT-G7)
Measured: 15 minutes
Symptoms distress Assessments
Taiwanese Version of the M.D. Anderson symptom Inventory (MDASI-T)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled, double blind, cross-over study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Chung Hung, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947969
- Sponsor's protocol ID
- REC110-09
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue
- ClinicalTrials.gov ID
- NCT04947969
- Acronym / sponsor ID
- REC110-09
- Conditions
- Cancer-related Fatigue
- Keywords
- Laser acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled, double blind, cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Rear laser acupuncture group | Experimental | Device: laser acupuncturePatients in the Real laser acupuncture group will receive real laser pen irradiation. |
| Shame laser acupuncture group | Sham comparator | Device: laser acupuncturePatients in the Shame laser acupuncture group will receive shame laser pen irradiation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have given a diagnosis of cognitive impairment are unable to completely the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser acupunctureThis 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. | Device | Rear laser acupuncture group, Shame laser acupuncture group |
Primary outcome
Cancer-related fatigue evaluation
Time frame: 30 minutes
ICD-10 Fatigue Criteria Brief Fatigue inventory-Taiwan Form
Cancer-related fatigue Assessment
Time frame: 15 minutes
Brief Fatigue Inventory-Taiwanese (BFI-T)
2 secondary outcomes
Quality of Life Assessments
Time frame: 15 minutes
Symptoms distress Assessments
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture in people with Cancer-related Fatigue, run by Taichung Tzu Chi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Chung Hung, Dr. (886-911856726, wuchunghung1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related fatigue evaluation (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.