A Nutritional Intervention for Improving Surgical Outcomes in Head and Neck Cancer Patients

Status: complete

This clinical trial evaluates how a nutritional intervention prior to surgery (pre-operative) affects surgical outcomes in patients with head and neck cancers. Inadequate nutrition (malnutrition) increases the rate of cancer treatment-related complications, and malnutrition is a risk factor for poorer outcomes in head and neck cancer patients. Nutritional interventions prior to radiation and chemotherapy treatments have been shown to improve outcomes, but the effects of a nutritional intervention on surgical outcomes are not known. This clinical trial examines how a nutritional intervention prior to surgery affects outcomes in head and neck cancer patients.

Inclusion Criteria

Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic
Will be undergoing complex head and neck reconstructive surgery
Will have a clean contaminated wound class
Patients who will be undergoing primary surgery for their cancer treatment

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 patient-generated subjective goal assessment [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

PRIMARY OBJECTIVES:

I. To improve patient nutritional status from time of diagnosis to surgical treatment.

II. To study the effect of nutritional intervention on surgical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients attend a dietician consultation at baseline (2-6 weeks before surgery) and at time of surgery. Patients also receive educational materials and Boost or Ensure nutritional supplement drinks for 2-6 weeks before surgery.

ARM II: Patients receive standard pre-operative care prior to surgery.

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A Nutritional Intervention for Improving Surgical Outcomes in Head and Neck Cancer Patients

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