Bawei Aiguning Granules For Lung Cancer Bone Metastases: A Randomized, Double-blind, Placebo-Controlled Trial...

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Bone metastases (BM) are a common complication of lung cancer, leading to skeletal-related events (SREs) and pain.
• Effective supportive management strategies for BM in lung cancer patients are crucial.

Purpose of the Study:

• To evaluate the efficacy and safety of Bawei Aiguning Granules (BWAGN) combined with standard bone-targeted therapy in lung cancer patients with BM.
• To assess the impact of BWAGN on SREs, pain, quality of life, and survival.

Main Methods:

• Prospective, multicenter, randomized, double-blind, placebo-controlled trial.
• 156 patients randomized across six centers.
• Primary endpoint: 1-year incidence of SREs. Secondary endpoints include pain, quality of life, survival, and safety assessments.

Main Results:

• Descriptive observations from one participant showed no SREs during follow-up.
• Serial Electron Computed Tomography (ECT) revealed no new bone progression or SRE-related changes.
• Favorable changes in functional status, symptom burden, and tumor markers were noted, with stable safety assessments.

Conclusions:

• Preliminary descriptive data suggest potential benefits of BWAGN in managing lung cancer with bone metastases.
• Further research and completion of the full study cohort are necessary to draw definitive conclusions on efficacy and safety.