Skip to nav Skip to content
  • Cancer Type: Multiple
  • Study Type: Supportive Care
  • NCT#: NCT06337552
  • Phase: N/A
Learn More
  • Overview

    Study Title:

    A Randomized High-Fermented Food Intervention among Cancer Patients (The FEED Trial)


    This Study will determine if a fermented foods (FF) dietary intervention (called FEED-FF) will be feasible and acceptable among participants with rectal cancer, and effective in modifying biomarkers that may be relevant in tumor responsiveness to neoadjuvant chemoradiation.


    Specific Aim #1: To establish feasibility and acceptability of the FEED-FF intervention via a pilot randomized clinical trial among locally advanced rectal cancer patients (N=15 FEED-FF and N=15 standard usual care [SUC]). Specific Aim #2 To explore the effects of the FEED-FF diet on local immune-related biomarkers, the gut microbiome, and quality of life. Specific Aim #3 To explore the effects of the FEED-FF diet on clinical response to chemoradiation.

  • Inclusion Criteria

      Inclusion Criteria:
    • 18 years of age or older
    • Patient must be diagnosed with locally advanced rectal cancer (stage II-III)
    • Patient must be receiving neoadjuvant chemoradiation at Moffitt Cancer Center
    • Patient must be able to pick up fermented foods (FFs) once/weekly at the PEARL research kitchen
    • Patient must be able to speak and read English
    • Patient must be able to consume foods orally
    • Patient must be able to provide informed consent
  • Exclusion Criteria

      Exclusion Criteria:
    • Patient cannot have had any antibiotic use within 1 month prior to baseline
    • Patient is currently using probiotics and unwilling to cease probiotic use
    • Patient has previously had surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
    • Patient has Inflammatory bowel conditions (e.g., ulcerative colitis, Crohn’s disease)
    • Patient has Immunosuppressive or autoimmune conditions (e.g., lupus, Graves disease, rheumatoid arthritis, psoriasis)
    • Patient has Infectious disease diagnosed less than 1 month prior to baseline
    • Patient is already consuming greater than or equal to 2 servings of FFs/day
    • Patient was previously diagnosed with a mast cell disorder or histamine allergy

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

Clinical Trial Search