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

NCT ID: NCT06337552

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
Locally Advanced
Rectal Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm

Primary purpose: Supportive Care

Masking: Single (Care Provider)

Masking description: Clincial response will be determined in clinic when patients undergo blinded tumor assessments by standard digital rectal exam, endoscopy, and rectal MRI at baseline and at the end of the intervention.

Intervention:

Intervention type: Other
Intervention name: FEED-FF
Description: 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.
Arm group label: FEED-FF

Intervention type: Other
Intervention name: Standard of Care (SUC)
Description: 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.
Arm group label: Standard of Care (SUC)

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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Status: Recruiting

Contact:
Last name: Stephanie Hogue

Phone: 813-745-1891
Email: Stephanie.Hogue@moffitt.org

Investigator:
Last name: Doratha (Armen) Byrd, MPH, PhD
Email: Principal Investigator

Investigator:
Last name: Sylvia Crowder, PhD, RDN, LDN
Email: Principal Investigator

Start date: April 4, 2024

Completion date: March 2027

Lead sponsor:
Agency: H. Lee Moffitt Cancer Center and Research Institute
Agency class: Other

Source: H. Lee Moffitt Cancer Center and Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06337552
http://www.moffitt.org/clinical-trials-research/clinical-trials/

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