RecruitingNot ApplicableNCT07483112

Fiber-Boost Randomized Controlled Trial

Multicenter, Randomized, Controlled Trial to Study the Effects of a High-Fiber Dietary Intervention on ctDNA Clearance and the Microbial and Immunological Landscape in Patients With Advanced Non-Small Cell Lung Cancer Receiving PD-1/PD-L1-Targeted Monotherapy (Fiber-Boost)


Sponsor

Cantonal Hospital of St. Gallen

Enrollment

42 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

In the present study 'Fiber-Boost', we investigate how a high-fiber diet affects the immunotherapy of advanced lung cancer and what effects it has on the gut microbiome (i.e., the bacteria in the gut) as well as the immune system. Study participants will be assigned to either a test group or a control group. Only patients in the test group will undergo a high-fiber diet. The study lasts 6 weeks per patient and will be conducted at 4 centers within Switzerland. A total of 42 patients are planned to be included in the study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called Fiber-Boost — is testing whether adding a high-fiber diet supplement to standard immunotherapy (PD-1/PD-L1 checkpoint inhibitor) can improve outcomes for people with advanced non-small cell lung cancer (NSCLC). Research suggests gut bacteria (which are fed by dietary fiber) may influence how well immunotherapy works, and this trial tests that idea in patients. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of advanced or recurrent non-small cell lung cancer - Your cancer strongly expresses a protein called PD-L1 (≥50%), meaning immunotherapy alone is recommended - You do not have certain genetic mutations (EGFR, ALK, ROS1, etc.) that would require targeted therapy instead - This would be your first systemic treatment for advanced disease - You are in reasonably good physical condition (ECOG 0–2) with adequate blood counts, liver, and kidney function **You may NOT be eligible if...** - You have had another cancer within the past 3 years (with some exceptions for low-risk cancers) - You have recently taken antibiotics (within 10 days of starting treatment) - You are on immune-suppressing medications (e.g., high-dose steroids, methotrexate) - You have had an organ or tissue transplant - You have active autoimmune disease requiring treatment - You have uncontrolled diabetes or serious cardiovascular disease - You are currently taking a fiber supplement (OptiFibre or similar) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTHigh-fiber diet

Patients in the intervention arm will receive a high-fiber diet through daily consumption of a defined amount of plant-based fibers from a commercial product.


Locations(4)

Universitätsspital Basel

Basel, Switzerland

Kantonsspital Graubünden

Chur, Switzerland

HOCH Health Ostschweiz, Cantonal Hospital St.Gallen

Sankt Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

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NCT07483112


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