This trial evaluates giving an immunonutrition supplement to improve gut microbiome in patients undergoing surgery for head and neck squamous cell carcinoma. Surgery can weaken the immune system and leave patients vulnerable to infection and other complications. Immunonutritional supplements may help control the immune response by providing the body the nutrients it needs to avoid vulnerability and infections, decrease inflammation, and improve wound healing.
Additional locations may be listed on ClinicalTrials.gov for NCT05061316.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Define changes in diversity and relative abundance of the gut microbiome in malnourished patients with head and neck cancer (HNC) after a preoperative nutrition intervention.
SECONDARY OBJECTIVES:
I. Determine a gut microbiome profile associated with improved postoperative outcomes following major HNC surgery.
II. Measure changes in systemic inflammatory markers after a preoperative nutrition intervention and correlate with gut microbiome composition.
III. Define changes in diversity and relative abundance of the oral microbiome in malnourished patients with HNC after a preoperative nutrition intervention.
IV. Determine an oral microbiome associated with fistula formation following major HNC surgery.
OUTLINE:
Patients receive an immunonutrition drink orally (PO) twice per day (BID) for 5 days prior to standard of care surgery. Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients follow up at 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorCarissa M Thomas
