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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • High-fiber diet

    Dietary supplement

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: High-fiber dietExperimental treatment 1 intervention
Group B: No high-fiber dietNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

ctDNA clearance

Fraction of patients achieving complete ctDNA clearance at 6 weeks

Time frame
6 weeks

Secondary outcomes

1

ctDNA dynamics

ctDNA dynamics over 6 weeks

Time frame
3 and 6 weeks
2

Radiological treatment response

Objective radiological response (RECIST 1.1)

Time frame
6 weeks and 6 months
3

Disease control rate

6-months disease control rate (non-progressive disease at 6 months)

Time frame
6 months
4

Microbiota dynamics

Gut microbiota dynamics by shotgun metagenomics

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cantonal Hospital of St. Gallen

Lead sponsor

Source ClinicalTrials.gov
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