Head and Neck Cancer, Malnutrition
Conditions
Keywords
Cancer, Surgery, Malnutrition, Preoperative, Nutrition
Brief summary
The purpose of this study is to determine the impact of preoperative nutritional supplements on head and neck surgery patients.
Interventions
DIETARY_SUPPLEMENTNutritional Supplement
Oral nutritional supplementation
BEHAVIORALPreoperative Dietitian Consult
Nutritional assessment
BEHAVIORALEducation
Informational materials about nutrition
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic, have a new H&N cancer diagnosis, and have not undergone previous treatment for H&N cancer are eligible for this study. We will enroll only patients who will be undergoing primary surgery for their cancer treatment, and those undergoing primary radiation or primary chemoradiation for treatment will be excluded. All eligible patients will undergo nutritional screening using the PG-SGA. Those who screen positive for malnutrition (\>1 on the PG-SGA scale) will be randomized to either our standard care (control) versus nutritional intervention group.
Exclusion criteria
* Prior treatment for head and neck cancer. Those undergoing primary radiation or chemoradiation for their head and neck cancer. Vulnerable populations. Patients who screen as well nourished (\>1 on the PG-SGA scale) will be excluded as they do not require nutritional intervention. Patients who screen as severely malnourished (\>8 on the PG-SGA scale) will be excluded as these patients require intervention and should not be potentially randomized to our control arm. Patients requiring nasogastric tube feeding or gastrostomy tube feeding will be excluded. Patients are routinely evaluated by speech pathologist prior to surgery. Those in which there is concern for aspiration will be excluded as they will not be able to participate fully in the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scored Patient-Generated Subjective Global Assessment | Baseline and day of surgery | PG-SGA is an interdisciplinary patient assessment of weight, intake, symptoms, functional status, disease state, metabolic stress and nutritional physical examination |
Countries
United States
Outcome results
None listed