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Dietary Supplement

Nutritional Optimization for Head and Neck Cancer

N/A

Recruiting

Led By Barry Wenig, MD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be diagnosed with cancer of the head and neck and must be surgical candidates

Age >18 years

Must not have

Patients unable to tolerate oral intake by mouth or per enteral feeding tube

Patients with known distant metastases or other malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-op

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if giving a specific nutritional supplement to head and neck cancer patients undergoing surgery can reduce the chances of developing wound complications after the operation."

Who is the study for?

Adults over 18 with head and neck cancer who are about to have major surgery that requires a hospital stay of at least four days. They must have recent body imaging results, be willing to take Nestle IMPACT Advanced Recovery before and after surgery, and agree to sign the consent form.

What is being tested?

The trial is testing if special nutritional drinks (Nestle IMPACT AR) given before and after major head and neck surgery can reduce wound complications compared to standard tube feeds.

What are the potential side effects?

Potential side effects may include digestive issues due to the nutritional supplements, such as nausea or changes in bowel movements. However, specific side effects related to Nestle IMPACT AR are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have head or neck cancer and can undergo surgery.

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I am older than 18 years.

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I am scheduled for major head and neck surgery expected to require a hospital stay of 4+ days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot eat or receive nutrition by mouth or feeding tube.

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I have cancer that has spread to distant parts of my body or I have more than one type of cancer.

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I have galactosemia.

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I am not taking IMPACT or arginine supplements.

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I am not taking anabolic steroids but can be on corticosteroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the effect of perioperative use of Nestle Impact AR

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard enteral tube feedsExperimental Treatment1 Intervention

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 II: Nestle IMPACT ARExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met