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

NCT03261180 | Withdrawn DMC

• 4 other identifiers: STUDY00015929NCI-2017-01480IRB00015929P30CA069533
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of other post-operative complications

  Within 30 days after surgery

• Sarcopenia

  Within 30 days after major head and neck surgery

Other Outcomes (1)

• Sarcopenia-related gene expression

  Up to 30 days post-surgery

Study Arms (2)

Group I (Nestle Impact AR)

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Dietary Supplement: Nutritional Intervention

Group II (regular diet)

ACTIVE COMPARATOR

Patients receive regular diet.

Other: Best Practice; Other: Laboratory Biomarker Analysis

Interventions

Best Practice OTHER

Receive regular diet

Also known as: standard of care, standard therapy

Group II (regular diet)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (Nestle Impact AR); Group II (regular diet)

Nutritional Intervention DIETARY_SUPPLEMENT

Receive Nestle Impact AR

Group I (Nestle Impact AR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Daniel Clayburgh

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: November 30, 2017
• Primary Completion: August 10, 2020
• Study Completion: August 9, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)