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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337552
• Other study ID #: MCC-22709
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: March 2027

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Stephanie Hogue
• Phone: 813-745-1891
• Email: Stephanie.Hogue[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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.
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials Website