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Spots Global Cancer Trial Database for Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer

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Trial Identification

Brief Title: 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 ID: NCT03261180

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

OHSU Knight Cancer Institute, Portland, Oregon, United States

Contact Details

Name: Daniel Clayburgh

Affiliation: OHSU Knight Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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