Pregabalin for chronic cough due to lung cancer: randomized, double-blind, placebo-controlled trial.

Background: Developing effective therapies for cough in lung cancer is an unmet need Neuromodulators like pregabalin may act centrally as cough suppressants.

Methods: Randomized double-blind placebo-controlled study in patients with locally advanced/metastatic lung cancer and at least 2 weeks of moderate or severe cough. Randomization was 1:1 to pregabalin 300 mg orally daily or matching placebo, both administered for 9 weeks. Primary endpoint was the change in cough severity as measured by the difference in VAS scores.

Results: Between Jul 2022 and Dec 2023, we enrolled 166 patients: 83 to each arm. Baseline cough severity was grade 2 in 128 (77.1%) and grade 3 in 38 (22.9%) patients; median cough duration was 12 weeks (IQR, 6-20). Systemic cancer-directed therapy was started in 78 (94.0%) and 72 (86.7%) patients in the pregabalin and placebo arms, respectively; P = 0.187. The mean (SD) VAS score (in mm) decreased from 71.58 (14.99) at baseline, to 45.54 (26.60) on day 7, and 22.27 (24.20) by week 9 in the pregabalin arm; and 71.75 (17.58), 46.35 (25.00), and 23.08 (22.42), respectively in the placebo arm; P = 0.877.

Conclusion: Pregabalin does not significantly decrease cough in patients with lung cancer. Systemic cancer-directed therapy is the most effective antitussive.

Clinical trial registration: Name of the registry: Clinical Trials Registry India Registration number: CTRI/2020/11/029275 Website: www.ctri.nic.in.