Lung Cancer Patients
Conditions
Brief 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 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
Interventions
DEVICEPress Needle Acupuncture and standart therapy
The patient will have a press needle applied, which will be removed on the seventh day.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
the participants and the outcome assessors will be blinded to group allocation
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for Pain | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - Lung (FACT-L) | Before therapy, Day 7, and Day 14 | 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 1. = A little bit 2. = Somewhat 3. = Quite a bit 4. = Very much Total scores range from 0 to 28 (higher scores indicate better quality of life). |
Countries
Indonesia
Contacts
Primary ContactYuanti Yunus Konda, MD
Outcome results
None listed