A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Masking Description
Clinical 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
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.
Intervention: FEED-FF (Other)
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.
Intervention: Standard of Care (SUC) (Other)
Outcomes
Primary Outcomes
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported