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.
Voluntary participation with full understanding of the study and signed informed consent form.
Age 18 to 75 years (inclusive) on the day of informed consent signing.
Histologically or cytologically confirmed malignancy.
Received at least one cycle of immune checkpoint inhibitor therapy.
Severe cardiac, cerebrovascular, renal, hematologic, or other serious systemic disease, including: NYHA Class III-IV heart failure; acute myocardial infarction or unstable angina within 6 months; severe post-stroke functional impairment (mRS greater than or equal to 3); progressive neurodegenerative disease; Child-Pugh Class B or C liver disease or acute liver failure; CKD stage 4-5 (eGFR less than 30 mL/min/1.73 m2) or requiring dialysis; absolute neutrophil count less than 1.5 x 10^9/L, platelet count less than 50 x 10^9/L, or Grade 3 or higher anemia (Hb less than 8 g/dL).
Severe allergic constitution or contraindications to the study treatment.
Significant psychiatric or psychological disorder, or doubts about the treatment plan.
Investigator judgment that the patient is unsuitable for the trial (e.g., poor follow-up adherence, refusal of supportive care).
Parallel
Spirulina-Bifidobacterium capsule
Dietary supplement1080 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Fish oil-grape seed-blueberry soft capsule
Dietary supplement1200 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Ganoderma spore oil
Dietary supplement800 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Methylprednisolone
DrugDose 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
Other interventionOral 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.
Time to immune-related pneumonitis downgrading
Time from randomization to the first imaging assessment, confirmed by the Independent Radiologic Review Committee, showing a reduction of at least 1 grade in pneumonitis severity compared with baseline, per CTCAE v5.0 and radiologic grading.
Proportion of participants with pneumonitis downgrading at 3 months
Proportion of participants in each arm with an IRRC-confirmed reduction of at least 1 pneumonitis grade from baseline within 3 months after randomization.
Change from baseline in 6-minute walk distance (6MWD)
Distance (meters) walked in 6 minutes on a flat, hard surface, measured according to a standardized protocol by trained personnel.
Change from baseline in modified Medical Research Council (mMRC) dyspnea scale
Self-reported dyspnea severity on the 0-4 mMRC scale, where 0 indicates no dyspnea except with strenuous exercise and 4 indicates dyspnea too severe to leave the house.
Change from baseline in St George's Respiratory Questionnaire (SGRQ) total score
Validated Chinese version of SGRQ; total score ranges 0-100, higher scores indicate worse respiratory-related quality of life.
Change from baseline in Leicester Cough Questionnaire (LCQ) score
Validated Chinese version of LCQ; total score ranges 3-21, higher scores indicate better cough-related quality of life.
Change in serum KL-6 (Krebs von den Lungen-6)
Change in serum inflammatory cytokines (IL-1 beta, IL-6, IL-10)
Change in immune cell subsets (ALC, CD4+ Th1/Th17, Tregs, NLR, AEC)
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