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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Non-Small Cell Lung Cancer; Rectal Cancer

Treatments: Other: Standard of Care (SUC); Other: FEED-FF

Study type: Interventional

Funder types: Other

Identifiers

NCT06337552

MCC-22709

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

FEED-FF

Experimental group

Description:

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.

Treatment:

Other: FEED-FF

Standard of Care (SUC)

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care (SUC)