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Nutritional Therapy Plus Corticosteroids for Immune Checkpoint Inhibitor-Related Pneumonitis
Sponsor: Guangzhou Institute of Respiratory Disease
Summary
This is a prospective, single-center, open-label, randomized controlled clinical trial evaluating whether the addition of a nutritional therapy regimen (Spirulina-Bifidobacterium capsules, fish oil-grape seed-blueberry soft capsules, and Ganoderma spore oil) to standard glucocorticoid therapy improves outcomes in patients with Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP), compared with standard glucocorticoid therapy alone. A total of 60 patients with malignancies who develop Grade 3-4 CIP (per CTCAE v5.0) after at least one cycle of immune checkpoint inhibitor therapy will be randomized 1:1 to the experimental or control arm. The primary endpoints are time to pneumonitis downgrading and the proportion of patients achieving downgrading at 3 months.
Official title: A Single-Center, Open-Label, Randomized Controlled Clinical Trial Comparing Nutritional Therapy (Spirulina-Bifidobacterium Capsules, Fish Oil-Grape Seed-Blueberry Soft Capsules, and Ganoderma Spore Oil) Combined With Standard Glucocorticoid Regimen Versus Standard Glucocorticoid Regimen Alone in the Treatment of Immune Checkpoint Inhibitor-Related Pneumonitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04
Completion Date
2029-10
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
Spirulina-Bifidobacterium capsule
1080 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Fish oil-grape seed-blueberry soft capsule
1200 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Ganoderma spore oil
800 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Methylprednisolone
Dose and tapering schedule per investigator assessment, referencing NCCN Guidelines 2025 version 1 for immune-related pneumonitis, continued until clinical and radiologic improvement and then tapered to discontinuation.
Matching placebo
Oral placebo capsules identical in appearance, color, shape, size, odor, taste, packaging, label, route, and dosing frequency to the investigational nutritional products, administered to maintain blinding and control for non-specific effects.
Locations (1)
The First Affiliated Hospital of Guangzhou Medical University, Department of Pulmonary Oncology
Guangzhou, Guangdong, China