NCT04923412

Vagus Nerve Preservation and Chronic Cough in Non-small Cell Lung Cancer Surgery

Status unknown NA Last updated 26 October 2022

What this trial tests

NA trial testing Pulmonary branch of vagus nerve preserved in Lung Cancer in 214 participants. Status unknown.

Timeline

1 July 2021

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Seoul National University Bundang Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	214
Start date	1 July 2021
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across South Korea

Drugs / interventions tested

• Pulmonary branch of vagus nerve preserved
• Pulmonary branch of vagus nerve not preserved

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Vagus Nerve Injuries — all drugs for Vagus Nerve Injuries →
• Cough — all drugs for Cough →

Sponsor

Seoul National University Bundang Hospital

Who can join

Adults 18 to 80, any sex, with Lung Cancer or Vagus Nerve Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lung cancer is the leading cause of cancer death worldwide. Surgical resection is the main treatment for resectable non-small-cell lung cancer (NSCLC), and lobectomy with systemic mediastinal lymph node dissection is the standard surgical method. However, a significant number of patients experience postoperative chronic cough; it is observed in about 60% of patients during the first year of outpatient clinic follow-up, and persistently lasts in about 24.7-50% during the 5 year follow-up period.

Several studies showed the association between vagus nerve and chronic cough. The bronchopulmonary vagal afferent C-fibers are responsible for cough, chest tightness and reflex bronchoconstrictions. It is expected that during the mediastinal lymph node dissection, the inevitable injuries to the pulmonary branch of vagus nerve is largely responsible for development of chronic cough. In other words, preservation of pulmonary branch of vagus nerve may reduce the incidence of chronic cough and relevant detrimental effects on quality of life.

Therefore, this prospective, randomized and controlled clinical study, aims to evaluate the effect of vagus nerve preservation on postoperative chronic cough in patients undergoing lobectomy with mediastinal lymph node dissection. In addition, the feasibility and oncologic safety of preserving pulmonary branch of vagus nerve during mediastinal lymph node dissection with minimally invasive surgery compared with conventional mediastinal lymph node dissection with minimally invasive surgery will also be investigated.

This trial will provide a new basis for oncologically feasible, safe and effective new surgical technique for mediastinal lymph node dissection in patients with early lung cancer undergoing minimally invasive surgery. Furthermore, the preventive effect of vagus nerve preservation on incidence of chronic cough will be objectively be proven and thus help to broaden the current knowledge of the role of vagus nerve and postoperative chronic cough.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. TRP Channels in Cancer: Signaling Mechanisms and Translational Approaches.
   Marini M, Titiz M, Souza Monteiro de Araújo D, Geppetti P, et al · · 2023 · cited 39× · PMID 37892239 · DOI 10.3390/biom13101557
2. Randomized controlled trials in lung cancer surgery: How are we doing?
   Wong LY, Li Y, Elliott IA, Backhus LM, et al · · 2024 · cited 1× · PMID 38690441 · DOI 10.1016/j.xjon.2024.01.008