Clinical trial NCT04449445: Perioperative Nutritional Optimization in Head and Neck Cancer Patients
Official title: Perioperative Nutritional Optimization in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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

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.

Primary outcomes:
measure: Assess the effect of perioperative use of Nestle Impact AR
timeFrame: 30 days post-op
measure: Assess the effect of perioperative use of Nestle Impact AR
timeFrame: 30 days
measure: Assess the effect of perioperative use of Nestle Impact AR
timeFrame: 30 days post-op
measure: Assess the effect of perioperative use of Nestle Impact AR
timeFrame: 30 days post-op
measure: Assess the effect of perioperative use of Nestle Impact AR
timeFrame: 30 days post-op
Secondary outcomes:
measure: Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications
timeFrame: 30 days post-op
measure: Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications
timeFrame: 30 days post-op
measure: Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications
timeFrame: 30 days post-op
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Barry Wenig, MD
role: PRINCIPAL_INVESTIGATOR
References: