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NCT06337552 | RECRUITING | Rectal Cancer

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

H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Condition or disease

Rectal Cancer

Non-Small Cell Lung Cancer

Intervention/treatment

FEED-FF

Standard of Care (SUC)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 54 participants
Masking : SINGLE
Masking Description : Clinical response will be determined in clinic when patients undergo blinded tumor assessments by standard digital rectal exam, endoscopy, and rectal MRI at baseline and at the end of the intervention.
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
Actual Study Start Date : 2024-04-04
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

Location Details

NCT06337552

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Locations

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, florida, United States, 33612