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Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation

NCT07554885 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

  • Immune Checkpoint Inhibitor-Related Pneumonitis
  • Drug-Related Side Effects and Adverse Reactions
  • Neoplasms

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.

Sponsors & Collaborators

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Principal Investigators

  • Chengzhi Zhou, MD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2029-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554885 on ClinicalTrials.gov