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

NCT ID: NCT06337552

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2027-03-31

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.

Conditions

Rectal Cancer; Non-Small Cell Lung Cancer

Keywords

Locally Advanced; Rectal Cancer; Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

FEED-FF

Participants will be asked to pick up the fermented foods at the Research Kitchen at Moffitt. Participants will be asked to eat 3-6 servings of FFs per day, from 1 week prior to treatment start through 12 weeks after treatment start/until the restaging scope is completed.

At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic.

Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints.

After the dietary intervention, participants will be asked to complete an exit survey to provide feedback on the study and intervention.

Group Type: EXPERIMENTAL

FEED-FF

Intervention Type: 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)

Participants will receive general healthy eating handouts similar to current usual care documents provided in clinic.

These handouts will detail typical healthy foods and the suggested level of intake, or servings per day.

At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SUC)

Intervention Type: 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.

Interventions

FEED-FF

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.

Intervention Type: OTHER

Standard of Care (SUC)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doratha (Armen) Byrd, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie Hogue

Role: CONTACT

Phone: 813-745-1891

Email: Stephanie.Hogue@moffitt.org

Facility Contacts

Stephanie Hogue

Role: primary

Other Identifiers

MCC-22709

Identifier Type: -

Identifier Source: org_study_id