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

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2024年11月26日

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Vanita Noronha,
Nandini Menon,
Vijay M. Patil,
Minit Shah,
Amit Joshi,
Srushti Shah,
Kavita Nawale,
Rohan Surve,
Gunj Bafna,
Shweta Jogdhankar,
Priyanka Shelar,
Ankush Shetake,
Ashish Singh,
Sushmita Salian,
Pundlik Jadhav,
Hetakshi Shah,
Neha Mer,
Ananya Vohra,
Swaratika Majumdar,
Shripad Banavali,
Rajendra Badwe,
Kumar Prabhash

摘要

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