This clinical trial tests the effect of FEED-FF, a fermented foods (FF) dietary intervention, during chemoradiotherapy on outcomes in patients with stage II-III rectal cancer and stage III-IV non-small cell lung cancer. Treatment for cancer can include surgery, chemoradiotherapy, or immunotherapy and many patients experience bowel issues after treatment. Studies have shown that the gut microbiome promotes tumor growth and can influence response to cancer therapy. Dietary intake directly impacts the composition and function of the gut microbiome. FFs, such as yogurt, cheese, kefir, and sauerkraut, are foods or beverages produced using controlled microbial growth, and enzymes and some FFs have known health benefits including reducing inflammation markers. FEED-FF during chemoradiotherapy may improve outcomes in rectal and non-small cell lung cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06337552.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Doratha Byrd
Phone: 813-745-1266
PRIMARY OBJECTIVES:
I. To establish feasibility and acceptability of the FEED-FF intervention via a pilot randomized clinical trial among locally advanced rectal cancer patients (N=15 FEED-FF and N=15 standard usual care [SUC]) undergoing
total neoadjuvant therapy (TNT) and lung cancer patients undergoing immunotherapy (N=12 FEED-FF and N=12 standard usual care [SUC]).
II. To explore the effects of the FEED-FF diet on local immune-related biomarkers, the gut microbiome, and quality of life.
III. To explore the effects of the FEED-FF diet on clinical response to total neoadjuvant therapy and immunotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (FEED-FF): Patients receive diet intervention handout and optional diet coaching session over 20 minutes on study. Patients also receive FFs provided by either the PEARL research kitchen or grocery delivery or pick up and eat 3-6 servings of FFs daily for 12.5 weeks, starting 1 week before standard of care chemoradiotherapy or immunotherapy. Patients may undergo standard of care magnetic resonance imaging (MRI) and endoscopy with tissue biopsy on study. Additionally, patients undergo blood and stool sample collection on study.
ARM II (SUC): Patients receive an optional diet coaching session over 20 minutes and general healthy eating handouts during standard of care chemoradiotherapy or immunotherapy on study. Patients also undergo blood and stool sample collection on study.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorDoratha Byrd
