RECRUITING

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

Quick Facts

Study Start:2022-05-10

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04449445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Barry Wenig, MD

CONTACT

312-996-6582

bwenig@uic.edu

Ginevra Ciavarella

CONTACT

312-996-6582

gciava1@uic.edu

Principal Investigator

Barry Wenig, MD

PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Study Locations (Sites)

University of Illinois at Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Barry Wenig, MD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-10

Study Completion Date2026-11

Study Record Updates

Study Start Date2022-05-10

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Cancer