Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05061316 |
| Other study ID # |
IRB-300007821 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2022 |
| Est. completion date |
January 1, 2026 |
Study information
| Verified date |
December 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
