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Perioperative Nutritional Optimization in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Isocaloric and iso-nitrogenous standard enteral tube feeds

Nestle IMPACT AR

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Age >18 years. Both men and women and 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 (PET-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.
All adult men and women with cancer of the head and neck undergoing surgery by the study PI's at UI Health will be considered for participation in this study without regard to race, gender or socioeconomic status.

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 immuno-nutrition 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.

Sites / Locations

University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard enteral tube feeds

Nestle IMPACT AR

Arm Description

Patients will be instructed to continue a normal diet before surgery. Post-operatively, patients will receive standard of care isocaloric and iso-nitrogenous standard enteral tube feeds

Patients will be encouraged to continue their regular diet until their surgery day. In addition, beginning 5 days before surgery, subjects will be instructed to drink three, 6 ounce cartons of Nestle IMPACT AR each day until their surgery. Post operatively patients who are able to eat orally, will be given three, 6 ounce cartons of Nestle IMPACT AR to drink each day for 5 days. Patients who are not able to tolerate an oral diet will be given Nestle IMPACT via a continuous tube feeding for 5 days through a temporary nasogastric feeding tube placed per standard post-operative care. Dosing of the tube feeding will be based on weight at a rate of approximately 70-75 cc/hour.

Outcomes

Primary Outcome Measures

Assess the effect of perioperative use of Nestle Impact AR

Assess the rate of post-operative wound infection

Assess the effect of perioperative use of Nestle Impact AR

Assess the rate of post-operative seroma

Assess the effect of perioperative use of Nestle Impact AR

Assess the rate of post-operative wound dehiscence

Assess the effect of perioperative use of Nestle Impact AR

Assess the rate of post-operative fistula formation

Assess the effect of perioperative use of Nestle Impact AR

Assess the rate of post-operative free tissue flap loss

Secondary Outcome Measures

Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia

Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

Exome sequencing will be performed to assess expression of sarcopenia-related genes in peripheral blood

Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

Measurement of mean muscle mass at L3 on cross-sectional body imaging

Full Information

NCT ID

NCT04449445

First Posted

June 23, 2020

Last Updated

April 6, 2021

Sponsor

University of Illinois at Chicago

1. Study Identification

Unique Protocol Identification Number

NCT04449445

Brief Title

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

Official Title

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Withdrawn

Why Stopped

COVID-19

Study Start Date

April 2021 (Anticipated)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery

Detailed Description

The purpose of this study is to determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. It is likely that many head and neck cancer patients suffer from sarcopenia, and this contributes to many wound complications, including wound infection, dehiscence, fistula formation, and free flap tissue loss. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

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

Standard enteral tube feeds

Arm Type

Other

Arm Description

Patients will be instructed to continue a normal diet before surgery. Post-operatively, patients will receive standard of care isocaloric and iso-nitrogenous standard enteral tube feeds

Arm Title

Nestle IMPACT AR

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Isocaloric and iso-nitrogenous standard enteral tube feeds

Intervention Description

Dietary supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Nestle IMPACT AR

Intervention Description

Dietary supplement

Primary Outcome Measure Information:

Title

Assess the effect of perioperative use of Nestle Impact AR

Description

Assess the rate of post-operative wound infection

Time Frame

30 days post-op

Title

Assess the effect of perioperative use of Nestle Impact AR

Description

Assess the rate of post-operative seroma

Time Frame

30 days

Title

Assess the effect of perioperative use of Nestle Impact AR

Description

Assess the rate of post-operative wound dehiscence

Time Frame

30 days post-op

Title

Assess the effect of perioperative use of Nestle Impact AR

Description

Assess the rate of post-operative fistula formation

Time Frame

30 days post-op

Title

Assess the effect of perioperative use of Nestle Impact AR

Description

Assess the rate of post-operative free tissue flap loss

Time Frame

30 days post-op

Secondary Outcome Measure Information:

Title

Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

Description

A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia

Time Frame

30 days post-op

Title

Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

Description

Exome sequencing will be performed to assess expression of sarcopenia-related genes in peripheral blood

Time Frame

30 days post-op

Title

Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications

Description

Measurement of mean muscle mass at L3 on cross-sectional body imaging

Time Frame

30 days post-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >18 years. Both men and women and 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 (PET-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. All adult men and women with cancer of the head and neck undergoing surgery by the study PI's at UI Health will be considered for participation in this study without regard to race, gender or socioeconomic status. 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 immuno-nutrition 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virginie Achim, MD

Organizational Affiliation

University of Illinois at Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Illinois at Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Perioperative Nutritional Optimization in Head and Neck Cancer Patients

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