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

Phase

N/A

Condition

Colon Cancer

Rectal Cancer

Non-small Cell Lung Cancer

Treatment

FEED-FF

Standard of Care (SUC)

Clinical Study ID

NCT06337552

MCC-22709

Ages > 18
All Genders

Study 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 Criteria

Inclusion

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 orother 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

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 colonor 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

Study Design