Non-Small Cell Lung CancerNCT07879768
Acupuncture and Laser Acupuncture for Advanced Non-Small Cell Lung Cancer
A study testing Needle Acupuncture and Laser Acupuncture in people with Non-Small Cell Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by China Medical University, Taiwan at 1 site in Taiwan.
Trial summary
This three-arm randomized controlled clinical trial evaluates the clinical efficacy and safety of needle acupuncture and laser acupuncture compared with placebo (sham) laser acupuncture as supportive care for patients with advanced non-small cell lung cancer (NSCLC, Stage IIIB-IV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Needle Acupuncture and Laser Acupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged >= 18 years
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), Stage IIIB/IIIC or stage IV disease
- Receiving or planned to receive standard of care systemic therapy, radiotherapy, or best supportive care
- ECOG performance status 0-2
- Presence of at least moderate symptom burden (e.g., dyspnea, fatigue, pain, sleep disturbance, or impaired quality of life)
- Ability to provide written informed consent
Who cannot join
- Bleeding tendency or severe thrombocytopenia contraindicating acupuncture
- Unstable cardiopulmonary disease or active systemic infection
- Local skin infection at proposed acupuncture sites
- Cognitive impairment preventing completion of questionnaires
- Concurrent participation in another interventional supportive-care trial
- Received acupuncture treatment within the last three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
China Medical University Hospital
Taichung, 404
Peter Karl Mayer, MD, PhD, +886-4-22053366 ext. Ext. 3007, piotrmayer@hotmail.com
About this study
Official title: A Three-Arm Randomized Controlled Trial of Needle Acupuncture and Laser Acupuncture as Supportive Care for Patients With Advanced Non-Small Cell Lung Cancer
This three-arm randomized controlled clinical trial evaluates the clinical efficacy and safety of needle acupuncture and laser acupuncture compared with placebo (sham) laser acupuncture as supportive care for patients with advanced non-small cell lung cancer (NSCLC, Stage IIIB-IV). The study aims to investigate improvements in lung cancer-specific quality of life, symptom burden, functional status, and sleep quality over a 6 to 8-week intervention period.
- Being tested
- Needle Acupuncture, Laser Acupuncture, Sham Laser Acupuncture
- Keywords
- Acupuncture, Laser Acupuncture, Supportive Care, Quality of Life, Advanced Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle AcupunctureProcedure or surgery
Participants receive standardized needle acupuncture applied bilaterally to core points (ST36, SP6, LI4, LU7) and unilaterally to GV20, plus 2-4 syndrome-directed optional points. Sterile, single-use disposable needles are manually stimulated to elicit de qi sensation and retained for 20-25 minutes per session. Treatment is administered twice weekly for 6-8 weeks (total 12-16 sessions).
Laser AcupunctureDevice
Participants receive active low-level laser acupuncture applied to the same core and symptom-directed acupuncture points as the needle group. Standardized laser parameters include wavelength of 650-830 nm, output power of 20-50 mW, energy dose of 1-3 Joules per point, and application time of 30-60 seconds per point. Sessions are delivered twice weekly for 6-8 weeks (total 12-16 sessions).
Sham Laser AcupunctureDevice
Participants receive sham laser acupuncture using an identical device that emits no therapeutic laser energy, applied to the identical acupuncture points and for the same treatment duration as the active laser group twice weekly for 6-8 weeks (total 12-16 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Needle Acupuncture Group | Experimental | Participants receive standardized needle acupuncture applied to predefined acupuncture points (core points: ST36, SP6, LI4, LU7 bilaterally, GV20 unilaterally; plus 2-4 syndrome-directed points) twice weekly for 6-8 weeks (total 12-16 sessions, 20-25 minutes per session), in addition to standard-of-care oncologic treatment. Receives: Procedure: Needle Acupuncture |
| Laser Acupuncture Group | Experimental | Participants receive active low-level laser acupuncture applied to the same acupuncture points as the needle group twice weekly for 6-8 weeks (wavelength: 650-830 nm, power: 20-50 mW, 1-3 J/point, 30-60 seconds/point), in addition to standard-of-care oncologic treatment. Receives: Device: Laser Acupuncture |
| Sham Laser Acupuncture Group | Sham comparator | Participants receive sham laser acupuncture using an identical device with no therapeutic laser emission, applied to the same points and for the same duration, in addition to standard-of-care oncologic treatment. Receives: Device: Sham Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Functional Assessment of Cancer Therapy-Lung Trial Outcome Index (FACT-L TOI) at 6-8 Weeks
Assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) Trial Outcome Index (TOI), which combines the Physical Well-Being, Functional Well-Being, and Lung Cancer Subscales. The score ranges from 0 to 84, with higher scores indicating better quality of life and lower symptom burden.
Measured: Baseline (Week 0) and End of intervention (Week 6 to 8)
Secondary outcomes (8)
Change from Baseline in FACT-L Lung Cancer Subscale (LCS) Score at 6-8 Weeks
Assessed using the Lung Cancer Subscale (LCS) of the Functional Assessment of Cancer Therapy-Lung questionnaire, evaluating symptoms such as dyspnea, cough, and chest discomfort. The score ranges from 0 to 28, with higher scores indicating fewer symptoms (better outcome).
Measured: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale Score at 6-8 Weeks
Assessed using the modified Medical Research Council (mMRC) dyspnea scale to evaluate breathlessness during daily activities. The scale ranges from Grade 0 to Grade 4, with higher scores indicating more severe breathlessness (worse outcome).
Measured: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in General Fatigue Scale - Taiwanese Version (GFS-T) Score at 6-8 Weeks
Assessed using the Taiwanese Version of the General Fatigue Scale (GFS-T) to measure cancer-related fatigue. The total score ranges from 14 to 70, with higher scores indicating greater severity and impact of fatigue (worse outcome).
Measured: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score at 6-8 Weeks
Assessed using the Pittsburgh Sleep Quality Index (PSQI) global score. The score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome).
Measured: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in 6-Minute Walk Distance (6MWD) at 6-8 Weeks
Functional exercise capacity measured by the distance walked in meters during a standardized 6-minute walk test (6MWT).
Measured: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in Lowest Oxygen Saturation (SpO2) During 6-Minute Walk Test at 6-8 Weeks
Measured as the lowest percentage of oxygen saturation recorded via pulse oximetry during the 6-minute walk test.
Measured: Baseline (Week 0) and End of intervention (Week 6 to 8)
Weekly Analgesic Consumption in Morphine Milligram Equivalents (MME)
Total opioid analgesic consumption calculated as weekly morphine milligram equivalents (MME/week).
Measured: Baseline (Week 0) through Week 8
Time to Clinically Meaningful Deterioration in FACT-L TOI
Time (in weeks or months) to confirmed clinically meaningful deterioration in the FACT-L Trial Outcome Index, defined as a decrease of at least 5 points from baseline.
Measured: From baseline up to 36 months (or study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, three-arm, randomized controlled trial evaluating needle acupuncture and laser acupuncture compared with placebo (sham) laser acupuncture in a 1:1:1 allocation ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Peter Karl Mayer, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879768
- Sponsor's protocol ID
- CMUH115-REC3-034
- Other IDs
- NSTC 115-2320-B-039-043-
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Arm Randomized Controlled Trial of Needle Acupuncture and Laser Acupuncture as Supportive Care for Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07879768
- Acronym / sponsor ID
- CMUH115-REC3-034
- Keywords
- Acupuncture, Laser Acupuncture, Supportive Care, Quality of Life, Advanced Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China Medical University, TaiwanUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 19 Oct 2026 (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.
This three-arm randomized controlled clinical trial evaluates the clinical efficacy and safety of needle acupuncture and laser acupuncture compared with placebo (sham) laser acupuncture as supportive care for patients with advanced non-small cell lung cancer (NSCLC, Stage IIIB-IV). The study aims to investigate improvements in lung cancer-specific quality of life, symptom burden, functional status, and sleep quality over a 6 to 8-week intervention period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, three-arm, randomized controlled trial evaluating needle acupuncture and laser acupuncture compared with placebo (sham) laser acupuncture in a 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Needle Acupuncture Group | Experimental | Procedure: Needle AcupunctureParticipants receive standardized needle acupuncture applied to predefined acupuncture points (core points: ST36, SP6, LI4, LU7 bilaterally, GV20 unilaterally; plus 2-4 syndrome-directed points) twice weekly for 6-8 weeks (total 12-16 sessions, 20-25 minutes per session), in addition to standard-of-care oncologic treatment. |
| Laser Acupuncture Group | Experimental | Device: Laser AcupunctureParticipants receive active low-level laser acupuncture applied to the same acupuncture points as the needle group twice weekly for 6-8 weeks (wavelength: 650-830 nm, power: 20-50 mW, 1-3 J/point, 30-60 seconds/point), in addition to standard-of-care oncologic treatment. |
| Sham Laser Acupuncture Group | Sham comparator | Device: Sham Laser AcupunctureParticipants receive sham laser acupuncture using an identical device with no therapeutic laser emission, applied to the same points and for the same duration, in addition to standard-of-care oncologic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged >= 18 years
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), Stage IIIB/IIIC or stage IV disease
- Receiving or planned to receive standard of care systemic therapy, radiotherapy, or best supportive care
- ECOG performance status 0-2
- Presence of at least moderate symptom burden (e.g., dyspnea, fatigue, pain, sleep disturbance, or impaired quality of life)
Key exclusion criteria (6 listed)
- Bleeding tendency or severe thrombocytopenia contraindicating acupuncture
- Unstable cardiopulmonary disease or active systemic infection
- Local skin infection at proposed acupuncture sites
- Cognitive impairment preventing completion of questionnaires
- Concurrent participation in another interventional supportive-care trial
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 |
|---|---|---|
| Needle AcupunctureParticipants receive standardized needle acupuncture applied bilaterally to core points (ST36, SP6, LI4, LU7) and unilaterally to GV20, plus 2-4 syndrome-directed optional points. Sterile, single-use disposable needles are manually stimulated to elicit de qi sensation and retained for 20-25 minutes per session. Treatment is administered twice weekly for 6-8 weeks (total 12-16 sessions). | Procedure or surgery | Needle Acupuncture Group |
| Laser AcupunctureParticipants receive active low-level laser acupuncture applied to the same core and symptom-directed acupuncture points as the needle group. Standardized laser parameters include wavelength of 650-830 nm, output power of 20-50 mW, energy dose of 1-3 Joules per point, and application time of 30-60 seconds per point. Sessions are delivered twice weekly for 6-8 weeks (total 12-16 sessions). | Device | Laser Acupuncture Group |
| Sham Laser AcupunctureParticipants receive sham laser acupuncture using an identical device that emits no therapeutic laser energy, applied to the identical acupuncture points and for the same treatment duration as the active laser group twice weekly for 6-8 weeks (total 12-16 sessions). | Device | Sham Laser Acupuncture Group |
Primary outcome
Change from Baseline in Functional Assessment of Cancer Therapy-Lung Trial Outcome Index (FACT-L TOI) at 6-8 Weeks
Time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)
Assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) Trial Outcome Index (TOI), which combines the Physical Well-Being, Functional Well-Being, and Lung Cancer Subscales. The score ranges from 0 to 84, with higher scores indicating better quality of life and lower symptom burden.
8 secondary outcomes
Change from Baseline in FACT-L Lung Cancer Subscale (LCS) Score at 6-8 Weeks
Time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale Score at 6-8 Weeks
Time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in General Fatigue Scale - Taiwanese Version (GFS-T) Score at 6-8 Weeks
Time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score at 6-8 Weeks
Time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in 6-Minute Walk Distance (6MWD) at 6-8 Weeks
Time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)
Change from Baseline in Lowest Oxygen Saturation (SpO2) During 6-Minute Walk Test at 6-8 Weeks
Time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)
Weekly Analgesic Consumption in Morphine Milligram Equivalents (MME)
Time frame: Baseline (Week 0) through Week 8
Time to Clinically Meaningful Deterioration in FACT-L TOI
Time frame: From baseline up to 36 months (or study completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Related trials for Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle Acupuncture and Laser Acupuncture in people with Non-Small Cell Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by China Medical University, Taiwan at 1 site in Taiwan.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Functional Assessment of Cancer Therapy-Lung Trial Outcome Index (FACT-L TOI) at 6-8 Weeks (time frame: Baseline (Week 0) and End of intervention (Week 6 to 8)). 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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.