NCT04449445Completed
Perioperative Nutritional Optimization in Head and Neck Cancer Patients
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 23 Jun 2020
- Start date
- 10 May 2022
- Primary completion date
- 11 Sept 2024
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Head and neck cancer
- NCT number
- NCT04449445
What you commit to
- Study type: Interventional
- Participants enrolled: 4
- From 10 May 2022 to the primary completion date, 11 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with known distant metastases or other malignancies.
- Psychiatric illness/social situations that would limit compliance with study requirements.
Other
- Patients unable to tolerate oral intake by mouth or per enteral feeding tube.
- Patients with galactosemia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.