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High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
NOT_RECRUITINGN/ASponsored by H. Lee Moffitt Cancer Center and Research Institute
No longer actively recruiting
PhaseN/A
SponsorH. Lee Moffitt Cancer Center and Research Institute
Started2024-04-04
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06337552
Summary
The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients and non-small cell lung cancer (NSCLC) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and NSCLC patients receiving immunotherapy.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria for GI Patients: * 18 years of age or older * Diagnosed with locally advanced rectal cancer (Stage II-III) * Will undergo neoadjuvant chemoradiation at Moffitt Cancer Center * Able to pick up FFs once/weekly at Moffitt * Able to speak and read English * Able to consume foods orally * Able to provide informed consent Inclusion Criteria for Thoracic Patients: * 18 years of age or older * Diagnosed with stage II-IV non-small cell lung cancer (NSCLC) * Will undergo Immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at Moffitt Cancer Center * Able to pick up FFs once/weekly at Moffitt * Able to speak and read English * Able to consume foods orally * Able to provide informed consent Exclusion Criteria: * Antibiotic use within 1 month prior to baseline * If currently using probiotics, unwillingness to cease probiotic use * Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor * Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease) * Infectious disease diagnosed \<1 month prior to baseline * Already consuming ≥2 servings of fermented foods/day * Previously diagnosed with a mast cell disorder or histamine allergy
Conditions4
CancerLung CancerNon Small Cell Lung CancerRectal Cancer
Locations1 site
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No longer actively recruiting
PhaseN/A
SponsorH. Lee Moffitt Cancer Center and Research Institute
Started2024-04-04
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06337552