Dietary intervention with fermented foods for patients with advanced rectal and lung cancer
A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
This study is testing if adding fermented foods to the diets of patients with advanced rectal and lung cancer can improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy, radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06337552 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and acceptability of a dietary intervention that includes fermented foods among patients with locally advanced rectal cancer and non-small cell lung cancer. The intervention aims to explore whether this diet can improve outcomes for rectal cancer patients undergoing chemoradiation and NSCLC patients receiving immunotherapy. Participants will be recruited from Moffitt Cancer Center and will receive fermented foods weekly as part of their treatment regimen. The study focuses on understanding the impact of dietary changes on cancer treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with locally advanced rectal cancer or stage II-IV non-small cell lung cancer who are undergoing specific treatments at Moffitt Cancer Center.
Not a fit: Patients who have recently used antibiotics or probiotics, or those who have received prior treatments for their cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance treatment outcomes for patients with advanced rectal and lung cancer.
How similar studies have performed: While dietary interventions in cancer care are being explored, this specific approach with fermented foods is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for GI Patients: * 18 years of age or older * Diagnosed with locally advanced rectal cancer (Stage II-III) * Will undergo neoadjuvant chemoradiation at Moffitt Cancer Center * Able to pick up FFs once/weekly at Moffitt * Able to speak and read English * Able to consume foods orally * Able to provide informed consent Inclusion Criteria for Thoracic Patients: * 18 years of age or older * Diagnosed with stage II-IV non-small cell lung cancer (NSCLC) * Will undergo Immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at Moffitt Cancer Center * Able to pick up FFs once/weekly at Moffitt * 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 * Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease) * 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
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Doratha (Armen) Byrd, PhD, MPH — Moffitt Cancer Center
- Study coordinator: Stephanie Hogue
- Email: Stephanie.Hogue@moffitt.org
- Phone: 813-745-1891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.