Lung Cancer PatientsNCT07112950
Press Needle Acupuncture for Pain and Quality of Life in Lung Cancer Patients
A study testing Press Needle Acupuncture and standart therapy in people with Lung Cancer Patients, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The purpose of this clinical trial is to evaluate the effect of press needle acupuncture on pain management and quality of life improvement in patients with lung cancer. The main question this study aims to answer is: Does press needle acupuncture, when combined with standard therapy, provide better pain relief and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Patients
- What is being tested?
- Press Needle Acupuncture and standart therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Aug 2025to 1 Dec 2025
- 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
- Patients with a confirmed diagnosis of lung cancer through histopathology or radiology.
- Lung cancer patients aged over 18 years.
- Stage III-IV lung cancer patients receiving therapy at Dr. Cipto Mangunkusumo National General Hospital (RSUPN) and Tangerang District General Hospital (RSUD Kabupaten Tangerang).
- Patients with a VAS score >10 mm for baseline pain and >40 mm during breakthrough pain.
- Willing to participate in the study until completion by signing the informed consent form.
Who cannot join
- Lung cancer patients with deteriorating general condition.
- Presence of wounds or infections at the press needle insertion site.
- History of allergy to stainless steel materials.
- Patients with blood clotting disorders: platelet count <50,000/μL, ANC <1000/mm³, or patients undergoing anticoagulant therapy with INR >2.142.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Yuanti Yunus Konda, MD, +6285240864987, yuanti.yunus@ui.ac.id
About this study
Official title: The Effect of Press Needle Acupuncture on Pain Reduction and Quality of Life Improvement in Lung Cancer Patients
The purpose of this clinical trial is to evaluate the effect of press needle acupuncture on pain management and quality of life improvement in patients with lung cancer.
The main question this study aims to answer is:
Read more
Does press needle acupuncture, when combined with standard therapy, provide better pain relief and quality of life improvement in lung cancer patients compared to standard therapy alone?
Researchers will compare press needle acupuncture to sham acupuncture to determine whether press needle acupuncture is more effective in reducing pain and improving quality of life.
Participants will:
Receive either press needle acupuncture or sham press needle acupuncture for 7 days
Visit the clinic once a week for examination and evaluation
Record improvements in pain intensity in a pain diary and assess quality of life using a quality of life questionnaire
- Conditions
- Lung Cancer Patients
- Being tested
- Press Needle Acupuncture and standart therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press Needle Acupuncture and standart therapyDevice
The patient will have a press needle applied, which will be removed on the seventh day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The press needle acupuncture and standart therapy Receives: Device: Press Needle Acupuncture and standart therapy |
| Control Group | Sham comparator | The sham press needle acupuncture and standart therapy Receives: Device: Press Needle Acupuncture and standart therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) for Pain
Pain intensity will be measured using the Visual Analogue Scale (VAS), which consists of a horizontal or vertical line 10 cm (100 mm) in length, representing a continuum of pain intensity from:
0 = No pain at all
10 = Worst imaginable pain
Measured: Before therapy, Day 1, Day 3, Day 7, and Day 14
Secondary outcomes (1)
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Quality of life will be assessed using the FACT-L questionnaire, consisting of 37 items rated on a 0-4 Likert scale:
0 = Not at all
- = A little bit
- = Somewhat
- = Quite a bit
- = Very much
Total scores range from 0 to 28 (higher scores indicate better quality of life).
Measured: Before therapy, Day 7, and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start11 Aug 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Press needle acupuncture and standart therapy will be designated as the intervention group, while the sham press needle acupucnture and standart therapy will be designated as the control group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanti Yunus Konda, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee of Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112950
- Sponsor's protocol ID
- 25-05-0758
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Press Needle Acupuncture on Pain Reduction and Quality of Life Improvement in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT07112950
- Acronym / sponsor ID
- 25-05-0758
- Conditions
- Lung Cancer Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 11 Aug 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Aug 2025 (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 purpose of this clinical trial is to evaluate the effect of press needle acupuncture on pain management and quality of life improvement in patients with lung cancer.
The main question this study aims to answer is:
Does press needle acupuncture, when combined with standard therapy, provide better pain relief and quality of life improvement in lung cancer patients compared to standard therapy alone?
Researchers will compare press needle acupuncture to sham acupuncture to determine whether press needle acupuncture is more effective in reducing pain and improving quality of life.
Participants will:
Receive either press needle acupuncture or sham press needle acupuncture for 7 days
Visit the clinic once a week for examination and evaluation
Record improvements in pain intensity in a pain diary and assess quality of life using a quality of life questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Press needle acupuncture and standart therapy will be designated as the intervention group, while the sham press needle acupucnture and standart therapy will be designated as the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Press Needle Acupuncture and standart therapyThe press needle acupuncture and standart therapy |
| Control Group | Sham comparator | Device: Press Needle Acupuncture and standart therapyThe sham press needle acupuncture and standart therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a confirmed diagnosis of lung cancer through histopathology or radiology.
- Lung cancer patients aged over 18 years.
- Stage III-IV lung cancer patients receiving therapy at Dr. Cipto Mangunkusumo National General Hospital (RSUPN) and Tangerang District General Hospital (RSUD Kabupaten Tangerang).
- Patients with a VAS score >10 mm for baseline pain and >40 mm during breakthrough pain.
- Willing to participate in the study until completion by signing the informed consent form.
Key exclusion criteria (4 listed)
- Lung cancer patients with deteriorating general condition.
- Presence of wounds or infections at the press needle insertion site.
- History of allergy to stainless steel materials.
- Patients with blood clotting disorders: platelet count <50,000/μL, ANC <1000/mm³, or patients undergoing anticoagulant therapy with INR >2.142.
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 |
|---|---|---|
| Press Needle Acupuncture and standart therapyThe patient will have a press needle applied, which will be removed on the seventh day. | Device | Control Group, Intervention Group |
Primary outcome
Visual Analogue Scale (VAS) for Pain
Time frame: Before therapy, Day 1, Day 3, Day 7, and Day 14
Pain intensity will be measured using the Visual Analogue Scale (VAS), which consists of a horizontal or vertical line 10 cm (100 mm) in length, representing a continuum of pain intensity from: 0 = No pain at all 10 = Worst imaginable pain
1 secondary outcome
Functional Assessment of Cancer Therapy - Lung (FACT-L)
Time frame: Before therapy, Day 7, and Day 14
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 8 Aug 2025.
- Individual participant dataSharing planned: No
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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.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee of Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Press Needle Acupuncture and standart therapy in people with Lung Cancer Patients, run by Universitas Indonesia at 1 site in Indonesia.
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 5 inclusion and 4 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 8 Aug 2025. 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 Indonesia. 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?
Contact Yuanti Yunus Konda, MD (+6285240864987, yuanti.yunus@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) for Pain (time frame: Before therapy, Day 1, Day 3, Day 7, and Day 14). 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 8 Aug 2025.