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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/