Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer

PRIMARY OBJECTIVES:

I. Assess the effect of perioperative use of Nestle Impact Advanced Recovery (AR) on the rate
of post-operative wound complications within 30 days after major head and neck surgery.

SECONDARY OBJECTIVES:

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

II. Assess whether Nestle IMPACT AR decreases the rate of other post-operative complications
such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile
colitis within 30 days of surgery, as well as length of hospital stay.

TERTIARY OBJECTIVES:

I. Assess changes in muscle metabolic gene expression at the time of surgery associated with
sarcopenia and IMAPCT treatment.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive Nestle Impact AR for 5 days before and after surgery in addition to
regular diet.

GROUP I: Patients receive regular diet.

After completion of study, patients are followed up for 30 days post-surgery.

Inclusion Criteria:

- 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 (positron emission tomography
[PET]-computed tomography [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

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 immunonutrition 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

- Excluded patients will be allowed to participate in the trial on an observational
basis only