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

IF 6.4 1区医学 Q1 ONCOLOGY British Journal of Cancer Pub Date : 2024-11-26 DOI:10.1038/s41416-024-02913-2

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

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Abstract

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.

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普瑞巴林治疗肺癌引起的慢性咳嗽：随机、双盲、安慰剂对照试验。

背景：开发治疗肺癌咳嗽的有效疗法是一项尚未满足的需求：开发治疗肺癌咳嗽的有效疗法是一项尚未满足的需求神经调节剂（如普瑞巴林）可作为中枢镇咳剂：方法：随机双盲安慰剂对照研究，研究对象为局部晚期/转移性肺癌患者，咳嗽症状为中度或重度咳嗽至少2周。按 1:1 随机分配普瑞巴林 300 毫克，每天口服或匹配安慰剂，均用药 9 周。主要终点是咳嗽严重程度的变化，以VAS评分的差异来衡量：从 2022 年 7 月到 2023 年 12 月，我们共招募了 166 名患者：每组 83 人。128名患者（77.1%）的基线咳嗽严重程度为2级，38名患者（22.9%）为3级；中位咳嗽持续时间为12周（IQR，6-20）。普瑞巴林治疗组和安慰剂治疗组分别有 78 例（94.0%）和 72 例（86.7%）患者开始接受系统性癌症指导治疗；P = 0.187。普瑞巴林治疗组的平均（标度）VAS评分（以毫米为单位）从基线时的71.58（14.99）降至第7天的45.54（26.60），第9周降至22.27（24.20）；安慰剂治疗组的平均（标度）VAS评分（以毫米为单位）分别为71.75（17.58）、46.35（25.00）和23.08（22.42）；P = 0.877：普瑞巴林不会明显减轻肺癌患者的咳嗽症状。临床试验注册：登记处名称：印度临床试验登记处临床试验注册：注册机构名称：印度临床试验注册机构注册号：CTRI/2020/11/02CTRI/2020/11/029275 网站：www.ctri.nic.in.

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来源期刊

British Journal of Cancer 医学-肿瘤学

CiteScore

15.10

自引率

1.10%

发文量

383

审稿时长

6 months

期刊介绍： The British Journal of Cancer is one of the most-cited general cancer journals, publishing significant advances in translational and clinical cancer research.It also publishes high-quality reviews and thought-provoking comment on all aspects of cancer prevention,diagnosis and treatment.