Perioperative Nutritional Optimization in Head and Neck C... | NCT04449445

NCT04449445

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard enteral tube feeds	Other	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	Dietary Supplement: Isocaloric and iso-nitrogenous standard enteral tube feeds
Nestle IMPACT AR	Experimental	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.	Dietary Supplement: Nestle IMPACT AR

Name	Type	Description	Arm Group Labels	Other Names
Isocaloric and iso-nitrogenous standard enteral tube feeds	Dietary Supplement	Dietary supplement	Standard enteral tube feeds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative wound infection	30 days post-op
Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative seroma	30 days
Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative wound dehiscence	30 days post-op
Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative fistula formation	30 days post-op
Assess the effect of perioperative use of Nestle Impact AR	Assess the rate of post-operative free tissue flap loss	30 days post-op

Secondary Outcomes

Measure	Description	Time Frame
Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications	A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia	30 days post-op
Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

Eligibility Module

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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms