The Gut Microbiome As an Indicator of Readiness for Head & Neck Cancer Surgery

NCT05061316 | Completed

• 1 other identifier: IRB-300007821
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how a pre-operative nutritional intervention alters the gut microbiome and improves outcomes after major head and neck cancer surgery.

Conditions

Cancer of Head and Neck; Nutrition Aspect of Cancer

Outcome Measures

Primary Outcomes (1)

• Define changes in the gut microbiome in malnourished patients with head and neck cancer after a pre-operative nutrition intervention via analyses of stool samples.

  Stool samples will be collected prior to the nutrition intervention and after completing 5 days of intervention. Stool samples will be processed and sequenced for 16S microbiome analysis. The composition of the gut microbiome will be compared before and after the immunonutrition intervention.

  Baseline - 6 months

Study Arms (1)

Nutrition intervention group

EXPERIMENTAL

Participants will receive Nestlé Impact Advanced Recovery Immunonutrition two times daily for 5 days leading up to the date of surgery. Nestlé Impact Advanced Recovery will be administered either orally or through a feeding tube.

Dietary Supplement: Nestlé Impact Advanced Recovery

Interventions

Nestlé Impact Advanced Recovery DIETARY_SUPPLEMENT

Immunonutrition drink that helps support the immune system: reduces risk of prolonged hospital stay and complications after surgery.

Nutrition intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age 18+)
• Male or female
• Diagnosis of head and neck cancer that will be treated with major surgery
• Major surgeries included will be any free flap reconstruction, any regional flap reconstruction (including pec major, submental flap, and supraclavicular artery island flap), oral composite resection, oropharyngectomy, total laryngectomy, cutaneous malignancy if it includes a free flap or regional flap reconstruction, parotidectomy if it includes a free flap or regional flap reconstruction, maxillectomy with or without orbital exenteration, lateral temporal bone resection, and/or a radical neck dissection if it includes a free flap or regional flap reconstruction
• Diagnosis of moderate (Stage B) or severe (Stage C) malnutrition, based on the patient-generated subjective global assessment (PG-SGA)
• Ability to speak and comprehend English
• Ability to consent for themselves

You may not qualify if:

• Age less than 18 years
• Inability to speak and comprehend English
• Inability to consent for themselves
• Pregnancy
• Allergy to fish oil or fish
• Gastrointestinal disorders (IBD, colon or rectal cancer, previous colon or small intestine resection)
• Autoimmune disorders requiring medication
• Chronic immunosuppression (i.e., transplant patients)
• Leukemia
• Stage III or higher Chronic Kidney Disease (CKD)
• Cirrhosis
• Pancreatitis

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Carissa M. Thomas, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 29, 2021
• Study Start: March 11, 2022
• Primary Completion: October 31, 2023
• Study Completion: February 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)