NCT03261180

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

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive regular diet
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIETARY_SUPPLEMENT	Nutritional Intervention	Receive Nestle Impact AR

Timeline

• Start date: 2017-11-30
• Primary completion: 2020-08-10
• Completion: 2021-08-09
• First posted: 2017-08-24
• Last updated: 2020-02-25

Locations

1 site across 1 country: United States