search
Back to results

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

Primary Purpose

Head and Neck Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Laboratory Biomarker Analysis
Nutritional Intervention
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (Nestle Impact AR)

Group II (regular diet)

Arm Description

Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.

Patients receive regular diet.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
August 22, 2017
Last Updated
February 21, 2020
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03261180
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient funding
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
August 10, 2020 (Anticipated)
Study Completion Date
August 9, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (Nestle Impact AR)
Arm Type
Experimental
Arm Description
Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.
Arm Title
Group II (regular diet)
Arm Type
Active Comparator
Arm Description
Patients receive regular diet.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive regular diet
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Intervention
Intervention Description
Receive Nestle Impact AR
Primary Outcome Measure Information:
Title
Rate of post-operative wound complications
Description
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
Time Frame
Within 30 days after major head and neck surgery
Secondary Outcome Measure Information:
Title
Rate of other post-operative complications
Description
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
Time Frame
Within 30 days after surgery
Title
Sarcopenia
Description
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.
Time Frame
Within 30 days after major head and neck surgery
Other Pre-specified Outcome Measures:
Title
Sarcopenia-related gene expression
Description
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.
Time Frame
Up to 30 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Clayburgh
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs