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NCT Number: NCT06337552

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Rectal Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FEED-FF

Other

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.

Standard of Care (SUC)

Other

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.

Primary outcomes

  1. Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)

    Time frame: 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.

  2. Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients)

    Time frame: 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.

  3. Effects of FEED-FF diet on the gut microbiome

    Time frame: At 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.

  4. Effects of FEED-FF diet on local immune-related biomarkers

    Time frame: At 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.

  5. Effects of FEED-FF diet on quality of life

    Time frame: At 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.

  6. Efficacy of the FEED-FF intervention

    Time frame: At 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.

  7. Feasibility of the FEED-FF intervention

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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