Clinical Trial 22709

• Overview

  Study Title:

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

  Summary:

  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.

  Objective:

  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

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