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Perioperative Nutritional Optimization in Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449445
Recruitment Status : Suspended (COVID-19)
First Posted : June 26, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Virginie Achim, University of Illinois at Chicago

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Dietary Supplement: Isocaloric and iso-nitrogenous standard enteral tube feeds Dietary Supplement: Nestle IMPACT AR Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Perioperative Nutritional Optimization in Head and Neck Cancer Patients
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Standard enteral tube feeds
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
Dietary Supplement: Isocaloric and iso-nitrogenous standard enteral tube feeds
Dietary supplement

Experimental: Nestle IMPACT AR
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.
Dietary Supplement: Nestle IMPACT AR
Dietary supplement




Primary Outcome Measures :
  1. Assess the effect of perioperative use of Nestle Impact AR [ Time Frame: 30 days post-op ]
    Assess the rate of post-operative wound infection

  2. Assess the effect of perioperative use of Nestle Impact AR [ Time Frame: 30 days ]
    Assess the rate of post-operative seroma

  3. Assess the effect of perioperative use of Nestle Impact AR [ Time Frame: 30 days post-op ]
    Assess the rate of post-operative wound dehiscence

  4. Assess the effect of perioperative use of Nestle Impact AR [ Time Frame: 30 days post-op ]
    Assess the rate of post-operative fistula formation

  5. Assess the effect of perioperative use of Nestle Impact AR [ Time Frame: 30 days post-op ]
    Assess the rate of post-operative free tissue flap loss


Secondary Outcome Measures :
  1. Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications [ Time Frame: 30 days post-op ]
    A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia

  2. Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications [ Time Frame: 30 days post-op ]
    Exome sequencing will be performed to assess expression of sarcopenia-related genes in peripheral blood

  3. Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications [ Time Frame: 30 days post-op ]
    Measurement of mean muscle mass at L3 on cross-sectional body imaging



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449445


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Virginie Achim, MD University of Illinois at Chicago
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Responsible Party: Virginie Achim, Principal Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04449445    
Other Study ID Numbers: 2018-0051
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms