High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
- Conditions
- Rectal CancerNon-Small Cell Lung Cancer
- Interventions
- Other: Standard of Care (SUC)Other: FEED-FF
- Registration Number
- NCT06337552
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SUC) Standard of Care (SUC) Participants will receive general healthy eating handouts similar to current usual care documents provided in clinic. These handouts will detail typical healthy foods and the suggested level of intake, or servings per day. At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints. FEED-FF FEED-FF Participants will be asked to pick up the fermented foods at the Research Kitchen at Moffitt. Participants will be asked to eat 3-6 servings of FFs per day, from 1 week prior to treatment start through 12 weeks after treatment start/until the restaging scope is completed. At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints. After the dietary intervention, participants will be asked to complete an exit survey to provide feedback on the study and intervention.
- Primary Outcome Measures
Name Time Method Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients) At Baseline and Up to 12.5 Weeks 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.Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients) At Baseline and Up to 12.5 Weeks Clinical benefit to immune checkpoint inhibitor therapy will be measured in clinic by MRI/Endoscopy, comparing the FEED-FF arm to SUC arm.
Defined as the best response of complete tumor resolution (CR), Partial Response (PR), and stable tumor size (SD) within 12 months.
Progressive Disease (PD) within 12 months indicates no clinical benefit.Effects of FEED-FF diet on the gut microbiome At Baseline, Week 6.5 and Up to 12.5 Weeks 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.
Effects of FEED-FF diet on local immune-related biomarkers At Baseline and Up to 12.5 Weeks Measured by FFPE tissue slides; FEED-FF arm hypothesized to demonstrate enhanced immune response such as higher T-cell expression compared to SUC arm.
Effects of FEED-FF diet on quality of life At Baseline, Week 6.5 and Up to 12.5 Weeks 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.
Efficacy of the FEED-FF intervention At Baseline, Week 6.5 and Up to 12.5 Weeks 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.Feasibility of the FEED-FF intervention At Baseline, Week 6.5 and Up to 12.5 Weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States