Perioperative Nutritional Optimization in Head and Neck Cancer Patients

NCT ID: NCT04449445

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2026-11-30

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

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 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

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard enteral tube feeds

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

Group Type: OTHER

Isocaloric and iso-nitrogenous standard enteral tube feeds

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement

Nestle IMPACT AR

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.

Group Type: EXPERIMENTAL

Nestle IMPACT AR

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement

Interventions

Isocaloric and iso-nitrogenous standard enteral tube feeds

Dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Nestle IMPACT AR

Dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Barry Lloyd Wenig

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry Wenig, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Barry Wenig, MD

Role: CONTACT

bwenig@uic.edu

312-996-6582

Ginevra Ciavarella

Role: CONTACT

gciava1@uic.edu

312-996-6582

Facility Contacts

Barry Wenig, MD

Role: primary

bwenig@uic.edu

312-996-6582

Ginevra Ciavarella

Role: backup

gciava1@uic.edu

312-996-6582

Other Identifiers

2018-1147

Identifier Type: -

Identifier Source: org_study_id