Fiber-Boost Randomized Controlled Trial
ConditionNon-Small Cell Carcinoma of Lung
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCantonal Hospital of St. Gallen
About this trial
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 criteria
Qualifiers
Age ≥18 years
Written informed consent according to Swiss law and ICH/GCP regulations before inclusion and prior to any trial-specific procedures
Histologically or cytologically confirmed NSCLC
Advanced or recurrent NSCLC not amenable to curative treatment
Disqualifiers
Systemic treatment with an antibiotic within 10 days of ICB treatment/HFD intervention start
Concomitant immunosuppressive drugs including corticosteroids at a daily dose of ≥10mg prednisone equivalents, methotrexate, azathioprine, TNF-α inhibitors
Concurrent treatment with other experimental drugs or other anticancer therapy
Major surgical procedures within 14 days prior to inclusion as judged by the investigator
Trial design
Treatments tested in this trial
- High-fiber diet
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov