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OpenTrials
Completed

NCT Number: NCT04449445

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isocaloric and iso-nitrogenous standard enteral tube feeds

Dietary Supplement

Dietary supplement

Nestle IMPACT AR

Dietary Supplement

Dietary supplement

Primary outcomes

  1. Assess the effect of perioperative use of Nestle Impact AR

    Time frame: 30 days post-op

    Assess the rate of post-operative wound infection

  2. Assess the effect of perioperative use of Nestle Impact AR

    Time frame: 30 days

    Assess the rate of post-operative seroma

  3. Assess the effect of perioperative use of Nestle Impact AR

    Time frame: 30 days post-op

    Assess the rate of post-operative wound dehiscence

  4. Assess the effect of perioperative use of Nestle Impact AR

    Time frame: 30 days post-op

    Assess the rate of post-operative fistula formation

  5. Assess the effect of perioperative use of Nestle Impact AR

    Time frame: 30 days post-op

    Assess the rate of post-operative free tissue flap loss

Secondary outcomes

  1. Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

    Time frame: 30 days post-op

    A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia

  2. Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

    Time frame: 30 days post-op

    Exome sequencing will be performed to assess expression of sarcopenia-related genes in peripheral blood

  3. Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

    Time frame: 30 days post-op

    Measurement of mean muscle mass at L3 on cross-sectional body imaging

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2020
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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