|

High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

RECRUITINGN/ASponsored by H. Lee Moffitt Cancer Center and Research Institute
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

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

Moffitt Cancer Center
Tampa, Florida, 33612
Stephanie Hogue813-745-1891Stephanie.Hogue@moffitt.org

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.