Clinical trial NCT06548711: Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer
Official title: Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Cough
Lung Cancer
Lead sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Observation and exploration of the improvement in cough symptoms in postoperative lung cancer patients with Transcutaneous Acupoint Electrical Stimulation (TAES), the change in Cough Symptom Score (CSS) compared to baseline, the change in Visual Analog Scale (VAS) score for cough symptoms compared to baseline, the change in total score of Leicester Cough Questionnaire-Mandarin Chinese version (LCQ-MC) compared to baseline, and overall evaluation of treatment effectiveness by patients. A total of 120 postoperative lung cancer patients with cough were strictly selected according to the inclusion/exclusion criteria and treated and followed up according to the research plan requirements. Clinical observation forms were completed and clinical data were recorded in the database. Statistical analysis was performed on relevant clinical observation indicators to report research results and write related papers.

Detailed description: To obtain sufficient evidence from evidence-based medicine, prospective, random, blind, and controlled clinical trials are adopted to evaluate the effectiveness and safety of TEAS in treating postoperative cough in lung cancer patients. This study aims to provide a potential non-pharmacological treatment option for postoperative cough patients with lung cancer, improve the quality of life of postoperative lung cancer patients, identify the population that is more likely to benefit from TEAS treatment and provide a solid scientific basis and guidance for personalized acupuncture treatment for postoperative cough in lung cancer patients.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years old - Surgery performed under general anesthesia for radical resection of lung cancer or lung cancer resection combined with lymph node dissection.
* Pathological confirmation of primary lung cancer after surgery.
* Duration of persistent dry cough after lung surgery ≥2 weeks.
* Consciousness, ability to express opinions clearly, and voluntary signing of informed consent.

Exclusion Criteria:

* Patients diagnosed with acute respiratory system diseases within 1 month.
* Patients diagnosed with pneumonia based on chest X-ray.
* Patients with a history of asthma or tuberculosis.
* Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection, coagulation disorders (hypercoagulable state or bleeding tendency), or other severe systemic diseases.
* Patients who have used steroid drugs within the past 3 months.
* Patients who have taken angiotensin-converting enzyme inhibitors (ACEIs) within the past 6 months.
* Patients with surgical incisions, skin allergies, wounds, or infections in the treatment area.
* Patients who cannot tolerate transcutaneous acupoint electrical stimulation or withdraw during the procedure.
* Patients with contraindications to transcutaneous electrical stimulation or implanted electrophysiological devices.
* Patients who are pregnant or breastfeeding.

Primary outcomes:
measure: LCQ-MC
timeFrame: Prior to treatment (baseline), at the end of treatment (week 2), and 2 weeks after the end of treatment (week 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
References: