Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07396558
Eligibility Criteria:
Inclusion Criteria
* Adult patients diagnosed with advanced-stage lung cancer who are currently receiving palliative care only.
* Presence of chronic cancer-related chest pain lasting longer than 1 month, localized to the thoracic region due to chest wall invasion, pleural involvement, or bone metastases.
* Performance status ≤ 3 according to the Eastern Cooperative Oncology Group (ECOG), allowing placement of a subcutaneous port and maintenance of local anesthetic administration.
* Inadequate pain control with conventional analgesic therapies or clinical indication for the addition of regional analgesia.
* Ability to understand the study procedures and provide written informed consent after receiving a full explanation of the intervention.
Exclusion Criteria:
* Chest pain with radiation to the upper extremities, neck, or shoulder, suggestive of non-localized thoracic pain.
* Severe hepatic or renal dysfunction, or severe heart failure (New York Heart Association class III-IV).
* Local infection at the injection or port placement site, or uncontrolled systemic infection.
* Severe cachexia or insufficient subcutaneous tissue that does not allow safe coverage of the subcutaneous port.
* Known allergy to amide-type local anesthetics or other contraindications to regional anesthesia.
* Severe cognitive impairment, altered consciousness, or inability to cooperate with post-intervention monitoring.
* Lack of adequate caregiver support for home-based follow-up after discharge or inability to coordinate follow-up with local healthcare facilities.
* Severe coagulation disorders, defined as:
* International normalized ratio (INR) \> 1.5
* Activated partial thromboplastin time (aPTT) \> 40 seconds
* Fibrinogen \< 1.5 g/L
* Platelet count \< 50 × 10⁹/L.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07396558
Study Brief:
Protocol Section:
NCT07396558