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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01480 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB00015929 | Other Identifier | OHSU Knight Cancer Institute | |
| P30CA069533 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Nestle Impact AR) | Experimental | Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet. |
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| Group II (regular diet) | Active Comparator | Patients receive regular diet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive regular diet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of other post-operative complications | Will assess whether Nestle IMPACT Advanced Recovery (AR) decreases the rate of other post-operative complications within 30 days after surgery such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis as well as length of hospital stay. Will be analyzed using chi square testing. The analysis of the length of the stay (LOS) for patients in each arm will be analyzed using the Kaplan Meier method for estimation of summary statistics including the 25th, 50th (median), and 75th percentiles and associated 95% confidence intervals. Patients that die prior to |
| Measure | Description | Time Frame |
|---|---|---|
| Sarcopenia-related gene expression | Will asses messenger ribonucleic acid expression level of the sarcopenia-related genes MAFbx, MuRF1, Foxo1, Redd1, Sesn1, SELP, IL-6, BNIP3, and CTSL1, within skeletal muscle, and circulating levels of sarcopenia-associated exomes. Will be analyzed using chi square testing. | Up to 30 days post-surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Clayburgh | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Nutritional Intervention | Dietary Supplement | Receive Nestle Impact AR |
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| Within 30 days after surgery |
| Sarcopenia | Will assess whether sarcopenia is an independent risk factor for the development of 30-day post-operative wound complications. Will be analyzed using chi square testing. | Within 30 days after major head and neck surgery |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |