Status:
RECRUITING
Perioperative Nutritional Optimization in Head and Neck Cancer Patients
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
The purpose of this study is to determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. It is likely that...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04449445
Start Date
May 10 2022
End Date
November 1 2026
Last Update
May 7 2024
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612