Clinical trial NCT03261180: Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer
Official title: Perioperative Nutritional Optimization in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-08-24
Enrollment: 0
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: This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in improving surgery recovery in patients with head and neck cancer. Adding a nutritional supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head and neck cancer surgery may help to decrease the number of wound complications after surgery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of post-operative wound complications
timeFrame: Within 30 days after major head and neck surgery
Secondary outcomes:
measure: Rate of other post-operative complications
timeFrame: Within 30 days after surgery
measure: Sarcopenia
timeFrame: Within 30 days after major head and neck surgery
Other outcomes:
measure: Sarcopenia-related gene expression
timeFrame: Up to 30 days post-surgery
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Daniel Clayburgh
role: PRINCIPAL_INVESTIGATOR
References: