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NCT06337552

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

Active, Not Recruiting
NAAges 18+InterventionalSupportive care
H. Lee Moffitt Cancer Center and Research Institute
~39 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:FEED-FFStandard of Care (SUC)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
Measured over At Baseline and Up to 12.5 Weeks
+6 more outcomes measured

Conditions

Rectal Cancer
Non-Small Cell Lung Cancer

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Lung Non-Small Cell CarcinomaRectal Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Doratha (Armen) Byrd, PhD, MPH · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)At Baseline and Up to 12.5 Weeks

    Clinical response measured in clinic by MRI/Endoscopy/Digital rectal exam, comparing the FEED-FF arm to SUC arm. Indicators of clinical response are Complete Response, Near Complete Response, Incomplete Response, or Progressive Disease.

  • Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients)At Baseline and Up to 12.5 Weeks

    Clinical benefit to immune checkpoint inhibitor therapy will be measured in clinic by MRI/Endoscopy, comparing the FEED-FF arm to SUC arm. Defined as the best response of complete tumor resolution (CR), Partial Response (PR), and stable tumor size (SD) within 12 months. Progressive Disease (PD) within 12 months indicates no clinical benefit.

  • Effects of FEED-FF diet on the gut microbiomeAt Baseline, Week 6.5 and Up to 12.5 Weeks

    Measured by fecal biospecimen sample collection; FEED-FF arm hypothesized to demonstrate increases in short chain fatty acid (SCFA) producing bacteria and higher alpha diversity compared to SUC arm.

  • Effects of FEED-FF diet on local immune-related biomarkersAt Baseline and Up to 12.5 Weeks

    Measured by FFPE tissue slides; FEED-FF arm hypothesized to demonstrate enhanced immune response such as higher T-cell expression compared to SUC arm.

  • Effects of FEED-FF diet on quality of lifeAt Baseline, Week 6.5 and Up to 12.5 Weeks

    Measured by using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Survey; FEED-FF arm hypothesized to demonstrate more favorable QoL compared to SUC arm.

  • Efficacy of the FEED-FF interventionAt Baseline, Week 6.5 and Up to 12.5 Weeks

    Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention. Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.

  • Feasibility of the FEED-FF interventionAt Baseline, Week 6.5 and Up to 12.5 Weeks

    Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention. Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.