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

Head and Neck Carcinoma Clinical Trial

Official title:

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03261180
• Other study ID #: STUDY00015929
• Secondary ID: NCI-2017-01480IR
• Status: Withdrawn
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: August 9, 2021

Study information

• Verified date: February 2020
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 9, 2021
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Other:
• Best Practice
Receive regular diet
• Laboratory Biomarker Analysis
Correlative studies

Dietary Supplement:
• Nutritional Intervention
Receive Nestle Impact AR

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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