Clinical trial NCT06337552: High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
Official title: A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Non-Small Cell Lung Cancer
Keywords: Locally Advanced
Rectal Cancer
Non-Small Cell Lung Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
timeFrame: At Baseline and Up to 12.5 Weeks
measure: Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients)
timeFrame: At Baseline and Up to 12.5 Weeks
measure: Effects of FEED-FF diet on the gut microbiome
timeFrame: At Baseline, Week 6.5 and Up to 12.5 Weeks
measure: Effects of FEED-FF diet on local immune-related biomarkers
timeFrame: At Baseline and Up to 12.5 Weeks
measure: Effects of FEED-FF diet on quality of life
timeFrame: At Baseline, Week 6.5 and Up to 12.5 Weeks
measure: Efficacy of the FEED-FF intervention
timeFrame: At Baseline, Week 6.5 and Up to 12.5 Weeks
measure: Feasibility of the FEED-FF intervention
timeFrame: At Baseline, Week 6.5 and Up to 12.5 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Doratha (Armen) Byrd, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: