Preoperative Nutritional Intervention in Head and Neck Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the impact of preoperative nutritional supplements on head and neck surgery patients.

Official Title
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Preoperative Nutritional Intervention in Head and Neck Cancer

Conditions
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Malnutrition, Head and Neck Cancer

Intervention / Treatment
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* Dietary Supplement: Nutritional Supplement
* Behavioral: Preoperative Dietitian Consult
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard care | |
| Experimental: Intervention<br>Three-Fold Nutritional Intervention | Dietary Supplement: Nutritional Supplement<br>* Oral nutritional supplementation<br>Behavioral: Preoperative Dietitian Consult<br>* Nutritional assessment<br>Behavioral: Education<br>* Informational materials about nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Scored Patient-Generated Subjective Global Assessment | PG-SGA is an interdisciplinary patient assessment of weight, intake, symptoms, functional status, disease state, metabolic stress and nutritional physical examination | Baseline and day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Surgery, Malnutrition, Preoperative, Nutrition