Bawei Aiguning Granules For Lung Cancer Bone Metastases: A Randomized, Double-blind, Placebo-Controlled Trial Protocol With A Representative Case

Peng Zhao; Yuping Hong; Junli Chang; Suxia Guo; Binghan Yan; Chujie Zhou; Xiaobo Wang; Fulai Zhao; Junjie Tong; Xinyu Zhang; Lijing Jiao; Yabin Gong; Yongjun Wang; Xingyuan Sun; Yanping Yang

doi:10.3791/69906

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Method Article

Bawei Aiguning Granules For Lung Cancer Bone Metastases: A Randomized, Double-blind, Placebo-Controlled Trial Protocol With A Representative Case

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DOI:

10.3791/69906

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June 12th, 2026

Peng Zhao¹^,² , Yuping Hong¹^,² , Junli Chang¹^,² , Suxia Guo¹^,² , Binghan Yan¹^,² , Chujie Zhou¹^,² , Xiaobo Wang¹^,² , Fulai Zhao¹^,² , Junjie Tong¹^,² , Xinyu Zhang¹^,² , Lijing Jiao³ , Yabin Gong³ , Yongjun Wang¹^,² , Xingyuan Sun¹^,² , Yanping Yang¹^,²

¹Longhua Hospital, Shanghai University of Traditional Chinese Medicine, ²Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education, ³Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Summary

This protocol describes a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate Bawei Aiguning Granules as an adjunctive intervention for skeletal-related events in patients with lung cancer bone metastases. It also presents currently available descriptive observations from a representative participant.

Abstract

Bone metastases (BM) frequently lead to skeletal-related events (SREs) and significant pain in lung cancer patients, requiring more effective supportive management strategies. We designed a prospective, multicenter, randomized, double-blind, placebo-controlled trial to evaluate Bawei Aiguning Granules (BWAGN) in combination with standard bone-targeted therapy. A total of 156 patients will be randomized across six centers. The primary endpoint is the 1-year incidence of SREs. Secondary endpoints include time to first SRE, pain assessment, quality of life, survival, Traditional Chinese Medicine symptom score, and bone turnover markers. Safety will be assessed according to Common Terminology Criteria for Adverse Events v5.0. Alongside the trial protocol, this manuscript presents currently available descriptive observations from a representative participant. During follow-up, no SREs were documented, and serial Electron Computed Tomography (ECT) examinations showed no obvious new imaging abnormalities suggestive of bone progression or SRE-related change. Functional status, symptom burden, and tumor markers showed favorable changes over time, while routine safety assessments remained generally stable, with no adverse events or serious adverse events recorded. These observations are descriptive only and should be interpreted with caution. Definitive conclusions regarding efficacy and safety will require completion of the protocol-defined follow-up and formal analysis of the full study cohort.

Introduction

Lung cancer is the most common malignant tumor worldwide and remains the leading cause of cancer-related deaths, with approximately 2.5 million new cases and 1.8 million deaths annually¹^,². Its high mortality rate is primarily attributed to distant metastasis³, with bone being one of the most common sites of metastasis. Approximately 30–40% of patients develop BM during their disease course⁴^,⁵^,⁶. Once BM occurs, the median survival of patients is approximately 9 months^4<....