Can spirulina and fish oil tame immunotherapy lung side effects?
NCT ID NCT07554885
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding a mix of nutritional supplements (spirulina, bifidobacterium, fish oil, grape seed, blueberry, and ganoderma spore oil) to standard steroid treatment can help people with severe lung inflammation caused by cancer immunotherapy. About 60 adults with cancer who developed grade 3-4 pneumonitis will be randomly assigned to get either supplements plus steroids or steroids alone. The main goal is to see if the supplements speed up recovery of the lung inflammation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary participation with full understanding of the study and signed informed consent form. 2. Age 18 to 75 years (inclusive) on the day of informed consent signing. 3. Histologically or cytologically confirmed malignancy. 4. Received at least one cycle of immune checkpoint inhibitor therapy. 5. Grade 3-4 immune-related pneumonitis (per CTCAE v5.0 and radiologic grading). 6. ECOG performance status 0-2, with expected survival of more than 3 months. 7. Adequate organ function based on laboratory results (without transfusion, apheresis, erythropoietin, or granulocyte colony-stimulating factor support within 14 days before the first dose). Women of childbearing potential must have a negative serum pregnancy test within 7 days before first dose. Exclusion Criteria: 1. 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). 2. Severe allergic constitution or contraindications to the study treatment. 3. Significant psychiatric or psychological disorder, or doubts about the treatment plan. 4. Investigator judgment that the patient is unsuitable for the trial (e.g., poor follow-up adherence, refusal of supportive care). 5. Use of anti-tumor traditional Chinese medicine within 14 days before first dose. 6. History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). 7. Severe acute or chronic infection. 8. Known alcohol or drug abuse history. 9. Pregnancy or breastfeeding. 10. Use of antibiotics, probiotic food, or microecological preparations within 2 weeks before enrollment. 11. Prior treatment-related lung injury: (a) targeted-therapy-related pulmonary toxicity (prior EGFR-TKI, ALK inhibitor, VEGF inhibitor, or antibody-drug conjugate causing interstitial lung disease or pneumonitis that has not fully resolved, with radiologic fibrosis or persistent functional impairment); (b) thoracic radiation-related lung injury (radiation pneumonitis or radiation fibrosis with irreversible CT findings). 12. Use of another investigational drug within 28 days before first dose that, per investigator judgment, would interfere with evaluation of study treatment. 13. Gastrointestinal disorder precluding oral administration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Guangzhou Medical University, Department of Pulmonary Oncology
Guangzhou, Guangdong, 510120, China
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Other studies related to the condition(s) this trial covers.
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