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

NCT ID: NCT03261180

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2021-08-09

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.

Conditions

Head and Neck Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group I (Nestle Impact AR)

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

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Nutritional Intervention

Intervention Type: DIETARY_SUPPLEMENT

Receive Nestle Impact AR

Group II (regular diet)

Patients receive regular diet.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive regular diet

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Best Practice

Receive regular diet

Intervention Type: OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Nutritional Intervention

Receive Nestle Impact AR

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

standard of care; standard therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Daniel Clayburgh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Clayburgh

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCI-2017-01480

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB00015929

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00015929

Identifier Type: -

Identifier Source: org_study_id