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

A Randomized 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 to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiotherapy (CRT).

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: FEED-FF; Other: Standard of Care (SUC)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Hogue; Phone Number: 813-745-1891; Email: Stephanie.Hogue@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Stephanie Hogue; Phone Number: 813-745-1891; Email: Stephanie.Hogue@moffitt.org
      • Principal Investigator: Doratha (Armen) Byrd, MPH, PhD
      • Principal Investigator: Sylvia Crowder, PhD, RDN, LDN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Diagnosed with locally advanced rectal cancer (Stage II-III)
• Receiving neoadjuvant chemoradiation at Moffitt Cancer Center
• Able to pick up FFs once/weekly at the PEARL research kitchen
• 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
• Inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
• Immunosuppressive or autoimmune conditions (e.g., lupus, Graves disease, rheumatoid arthritis, psoriasis)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of the FEED-FF diet on clinical response to chemoradiation	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.	At Baseline and Up to 12.5 Weeks
Effects of FEED-FF diet on the gut microbiome	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.	At Baseline, Week 6.5 and Up to 12.5 Weeks
Effects of FEED-FF diet on local immune-related biomarkers	Measured by FFPE tissue slides; FEED-FF arm hypothesized to demonstrate enhanced immune response such as higher T-cell expression compared to SUC arm.	At Baseline and Up to 12.5 Weeks
Effects of FEED-FF diet on quality of life	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.	At Baseline, Week 6.5 and Up to 12.5 Weeks
Efficacy of the FEED-FF intervention	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.	At Baseline, Week 6.5 and Up to 12.5 Weeks
Feasibility of the FEED-FF intervention	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.	At Baseline, Week 6.5 and Up to 12.5 Weeks

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Doratha (Armen) Byrd, PhD, MPH, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Locally Advanced; Rectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: MCC-22709

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No