RecruitingNot ApplicableNCT06337552

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

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

54 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

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

Min Age: 18 Years

Inclusion Criteria14

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
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 Criteria7

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

Interventions

OTHERFEED-FF

3-6 servings of any combination of the following fermented foods/day (from 1 week prior to treatment to approximately 12 weeks after the start of treatment): Yogurt, cottage cheese, kefir, kombucha, sauerkraut, and kimchi.

OTHERStandard of Care (SUC)

Standard of Care (SUC) is the treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by health care professionals. Standard of Care will comprise general healthy eating handouts that describe typical healthy foods and the suggested level of servings per day.