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Can a simple drink reduce surgery complications in head and neck cancer?

NCT ID NCT04449445

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving head and neck cancer patients a special nutritional supplement (Nestle IMPACT AR) before and after major surgery could lower the chance of wound problems like infections or poor healing. Only 4 people took part, and researchers tracked complications such as wound infection, seroma, and fistula. The goal was to see if better nutrition around the time of surgery could improve recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nestle IMPACT AR (a specialized nutritional supplement)
What this could lead to
If it works, this could point toward a simple dietary supplement that helps prevent wound infections and other complications after major head and neck cancer surgery.
What could go wrong
This is a very small, early study with only 4 participants, so results may not apply to everyone. The supplement may not reduce complications as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4 people

The number who actually took part.

Started

May 2022

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.