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NOT YET RECRUITING
NCT07554885
NA

Nutritional Therapy Plus Corticosteroids for Immune Checkpoint Inhibitor-Related Pneumonitis

Sponsor: Guangzhou Institute of Respiratory Disease

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Spirulina-Bifidobacterium capsule

1080 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.

DIETARY_SUPPLEMENT

Fish oil-grape seed-blueberry soft capsule

1200 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.

DIETARY_SUPPLEMENT

Ganoderma spore oil

800 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.

DRUG

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.

OTHER

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