Nutritional support for head and neck cancer patients before surgery
Perioperative Nutritional Optimization in Head and Neck Cancer Patients
This study is testing if better nutrition before and after surgery can help head and neck cancer patients avoid complications like infections and tissue loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04449445 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether nutritional optimization can reduce post-operative wound complications in patients with head and neck cancer undergoing major surgery. The researchers will provide participants with nutritional supplementation using Nestle Impact Advanced Recovery before and after their surgical procedures. The hypothesis is that improved nutrition will help mitigate issues such as wound infection and tissue loss, which are common in this patient population. The study will include patients who are surgical candidates and have undergone recent imaging to confirm their condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with head and neck cancer who are scheduled for major surgical procedures.
Not a fit: Patients who are not surgical candidates or those with contraindications to nutritional supplementation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative complications for head and neck cancer patients, leading to better recovery outcomes.
How similar studies have performed: While the specific approach of using Nestle Impact Advanced Recovery is being tested here, similar nutritional optimization strategies have shown promise in reducing complications in other surgical populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Barry Wenig, MD — University of Illinois at Chicago
- Study coordinator: Barry Wenig, MD
- Email: bwenig@uic.edu
- Phone: 312-996-6582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.