Perioperative Nutritional Optimization in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449445
• Other study ID #: 2018-1147
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Barry Wenig, MD
• Phone: 312-996-6582
• Email: bwenig[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 many head and neck cancer patients suffer from sarcopenia, and this contributes to many wound complications, including wound infection, dehiscence, fistula formation, and free flap tissue loss. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• Isocaloric and iso-nitrogenous standard enteral tube feeds
Dietary supplement
• Nestle IMPACT AR
Dietary supplement

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative wound infection	30 days post-op
Primary	Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative seroma	30 days
Primary	Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative wound dehiscence	30 days post-op
Primary	Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative fistula formation	30 days post-op
Primary	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	Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications	A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia	30 days post-op
Secondary	Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications	Exome sequencing will be performed to assess expression of sarcopenia-related genes in peripheral blood	30 days post-op
Secondary	Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications	Measurement of mean muscle mass at L3 on cross-sectional body imaging	30 days post-op