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

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Dietary supplement: Nutritional Intervention; Other: Best Practice

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I (Nestle Impact AR); Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.	Other: Laboratory Biomarker Analysis; Correlative studies; Dietary supplement: Nutritional Intervention; Receive Nestle Impact AR
ACTIVE_COMPARATOR: Group II (regular diet); Patients receive regular diet.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Best Practice; Receive regular diet; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of post-operative wound complications	A patient is found to have a post-operative complication is one of the following is observed: wound infection, seroma, wound dehiscence, fistula formation, free tissue flap loss. A 2-sided 95% confidence interval will also be calculated for each arm, using exact methods, and chi square testing will be performed to compare the incidence of wound complications within 30 days after surgery between control and experimental groups. A multivariate analysis of the primary endpoint will be performed with logistic regression to include study treatment, presence of sarcopenia, prior radiation therapy, a	Within 30 days after major head and neck surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of other post-operative complications	Will assess whether Nestle IMPACT Advanced Recovery (AR) decreases the rate of other post-operative complications within 30 days after surgery such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis as well as length of hospital stay. Will be analyzed using chi square testing. The analysis of the length of the stay (LOS) for patients in each arm will be analyzed using the Kaplan Meier method for estimation of summary statistics including the 25th, 50th (median), and 75th percentiles and associated 95% confidence intervals. Patients that die prior to	Within 30 days after surgery
Sarcopenia	Will assess whether sarcopenia is an independent risk factor for the development of 30-day post-operative wound complications. Will be analyzed using chi square testing.	Within 30 days after major head and neck surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sarcopenia-related gene expression	Will asses messenger ribonucleic acid expression level of the sarcopenia-related genes MAFbx, MuRF1, Foxo1, Redd1, Sesn1, SELP, IL-6, BNIP3, and CTSL1, within skeletal muscle, and circulating levels of sarcopenia-associated exomes. Will be analyzed using chi square testing.	Up to 30 days post-surgery

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Daniel Clayburgh, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2017
• Primary Completion (ANTICIPATED): August 10, 2020
• Study Completion (ANTICIPATED): August 9, 2021

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (ACTUAL): August 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: STUDY00015929; P30CA069533 (U.S. NIH Grant/Contract); NCI-2017-01480 (REGISTRY: CTRP (Clinical Trial Reporting Program)); IRB00015929 (OTHER: OHSU Knight Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No