Perioperative Nutritional Optimization in Head and Neck Cancer Patients

NCT04449445 | Completed

• 1 other identifier: 2018-1147
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (5)

• Assess the effect of perioperative use of Nestle Impact AR

  Assess the rate of post-operative wound infection

  30 days post-op

• Assess the effect of perioperative use of Nestle Impact AR

  Assess the rate of post-operative seroma

  30 days

• Assess the effect of perioperative use of Nestle Impact AR

  Assess the rate of post-operative wound dehiscence

  30 days post-op

• Assess the effect of perioperative use of Nestle Impact AR

  Assess the rate of post-operative fistula formation

  30 days post-op

• Assess the effect of perioperative use of Nestle Impact AR

  Assess the rate of post-operative free tissue flap loss

  30 days post-op

Secondary Outcomes (3)

• Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

  30 days post-op

• Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

  30 days post-op

• Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

  30 days post-op

Study Arms (2)

Standard enteral tube feeds

OTHER

Patients will be instructed to continue a normal diet before surgery. Post-operatively, patients will receive standard of care isocaloric and iso-nitrogenous standard enteral tube feeds

Dietary Supplement: Isocaloric and iso-nitrogenous standard enteral tube feeds

Nestle IMPACT AR

EXPERIMENTAL

Patients will be encouraged to continue their regular diet until their surgery day. In addition, beginning 5 days before surgery, subjects will be instructed to drink three, 6 ounce cartons of Nestle IMPACT AR each day until their surgery. Post operatively patients who are able to eat orally, will be given three, 6 ounce cartons of Nestle IMPACT AR to drink each day for 5 days. Patients who are not able to tolerate an oral diet will be given Nestle IMPACT via a continuous tube feeding for 5 days through a temporary nasogastric feeding tube placed per standard post-operative care. Dosing of the tube feeding will be based on weight at a rate of approximately 70-75 cc/hour.

Dietary Supplement: Nestle IMPACT AR

Interventions

Isocaloric and iso-nitrogenous standard enteral tube feeds DIETARY_SUPPLEMENT

Dietary supplement

Standard enteral tube feeds

Nestle IMPACT AR DIETARY_SUPPLEMENT

Dietary supplement

Nestle IMPACT AR

Eligibility Criteria

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

You may qualify if:

• Age \>18 years. Both men and women and members of all races and ethnic groups will be included.
• Patients must be diagnosed with cancer of the head and neck and must be surgical candidates.
• Patients must be indicated for major head and neck surgery, defined as surgeries with an anticipated post-surgical hospital stay of 4 or more days. Examples of major surgeries include, but are not limited to, total laryngectomy, large oral cavity, oropharyngeal, salivary gland, or soft tissue resections requiring free flap or major regional flap (e.g. pectoralis major flap), and large skull base procedures requiring extensive skull base reconstruction.
• Patients must have cross-sectional body imaging (PET-CT or equivalent) performed within 4 weeks of study enrollment and available for review.
• Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery.
• Ability to understand and the willingness to sign a written informed consent document.
• All adult men and women with cancer of the head and neck undergoing surgery by the study PI's at UI Health will be considered for participation in this study without regard to race, gender or socioeconomic status.

You may not qualify if:

• Patients with known distant metastases or other malignancies.
• Patients unable to tolerate oral intake by mouth or per enteral feeding tube.
• Patients with galactosemia.
• Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study.
• Patients currently taking IMPACT or other immuno-nutrition products (arginine-containing supplements) will be excluded. Other forms of nutritional supplementation, such as caloric supplementation, tube feeding, or other dietary supplements are allowed on study.
• Patients currently taking anabolic steroids will be excluded. Patients taking corticosteroids are allowed on study.
• Psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Barry Wenig, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: May 10, 2022
• Primary Completion: September 11, 2024
• Study Completion: September 12, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)