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

Primary Purpose

Cancer of Head and Neck, Nutrition Aspect of Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nestlé Impact Advanced Recovery
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutrition intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2021
Last Updated
March 15, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05061316
Brief Title
The Gut Microbiome as an Indicator of Readiness for Head & Neck Cancer Surgery
Official Title
The Gut Microbiome as an Indicator of Readiness for Head & Neck Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Head and neck cancer (HNC) arises from the mucosal lining of the upper aerodigestive system. Tumor-associated pain and physical obstruction from the tumor can impair a patient's ability to eat, and this combined with the catabolic nature of cancer leads to significant weight loss.HNC patients have a high burden of moderate to severe malnutrition and cachexia with a rate of approximately 40%, and malnourishment at the time of HNC diagnosis is associated with poor survival. In addition, these malnourished patients have longer post-operative hospital length of stay, increased post-operative complications including infection, delayed wound healing, muscle weakness, impaired cardiac and respiratory symptoms, reduced response to adjuvant treatment, and decreased quality of life. Inflammation increases the risk of malnutrition and may play a role in the suboptimal response to certain nutrition interventions. Changes in diversity and relative abundance of gut bacteria in malnourished patients with head and neck cancer after a pre-operative nutrition intervention will be determined. Post-operative outcomes including wound complications, other surgical and medical complications, hospital length of stay, unintended readmission within 30 days and mortality after a pre-operative nutrition intervention will be recorded and compared to a historic control. Finally, changes in known markers of nutritional status (albumin, prealbumin, c-reactive protein (CRP), transferrin, thyroid stimulating hormone (TSH), comprehensive metabolic panel (CMP), and complete blood count (CBC)) and systemic inflammatory markers (Interleukin (IL)-1β, IL-6, IFNγ, TNF, IL-2, IL-4, IL-10, IL-12, IL-17) will be measured after a pre-operative nutrition intervention. The pre-operative nutrition intervention is Nestlé Impact Advanced Recovery Immunonutrition administered orally or through a feeding tube two times daily for 5 days leading up to the date of surgery (day -5 to -1). Nestlé Impact Advanced Recovery provides 280kcal, 11g total fat, 20g carbohydrates, and 26g protein per unit (250mL). In addition, it is enriched with L-arginine and omega-3 fatty acids, two components found to be essential for the beneficial effect of immunonutrition in a systematic review. Immunonutrition is a specially formulated diet that contains nutrients to modulate inflammation. Pre-operative nutrition interventions with immunonutrition have demonstrated a decrease in post-operative complications (35% vs 50%, p=0.034) and unplanned readmissions and shortened hospital stays (17 vs 6 days, p<0.001) in patients with HNC. Studies have shown that dietary interventions can improve wound healing and post-operative survival. Currently, nothing is known about the composition of the gut microbiome in malnourished patients with HNC and how that composition changes with an immunonutrition intervention. There is evidence that remote tissue healing is influenced by the gut microbiome. In mice undergoing a pre-operative nutrition intervention, there is a shift in the gut microbiome composition from Proteobacteria and Firmicutes to Bacteroidetes, which produce metabolites that impact the systemic immune system. The study hypothesis is the gut microbiome can serve as a marker of readiness for major surgery after a pre-operative nutrition intervention in patients with HNC. The investigators aim to treat malnourished patients with HNC with immunonutrition and examine changes in the gut microbiome composition to define a gut microbiome associated with decreased post-operative complications, improved markers of nutritional status, and decreased markers of systemic inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck, Nutrition Aspect of Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nestlé Impact Advanced Recovery
Intervention Description
Immunonutrition drink that helps support the immune system: reduces risk of prolonged hospital stay and complications after surgery.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carissa M. Thomas, MD, PhD
Phone
(205) 801-7887
Email
carissathomas@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carissa M. Thomas, MD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carissa M. Thomas, MD, PhD
Phone
205-801-7887
Email
carissathomas@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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