RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-04
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06337552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Antibiotic use within 1 month prior to baseline
  2. * If currently using probiotics, unwillingness to cease probiotic use
  3. * Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
  4. * Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
  5. * Infectious disease diagnosed \<1 month prior to baseline
  6. * Already consuming ≥2 servings of fermented foods/day
  7. * Previously diagnosed with a mast cell disorder or histamine allergy

Contacts and Locations

Study Contact

Stephanie Hogue
CONTACT
813-745-1891
Stephanie.Hogue@moffitt.org

Principal Investigator

Doratha (Armen) Byrd, PhD, MPH
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Doratha (Armen) Byrd, PhD, MPH, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Locally Advanced
  • Rectal Cancer
  • Non-Small Cell Lung Cancer

Additional Relevant MeSH Terms

  • Rectal Cancer
  • Non-Small Cell Lung Cancer