Preoperative Nutritional Intervention in Head and Neck Cancer

University of Kansas

Status: Completed

Conditions: Malnutrition; Head and Neck Cancer

Treatments: Dietary Supplement: Nutritional Supplement; Behavioral: Education; Behavioral: Preoperative Dietitian Consult

Study type: Interventional

Funder types: Other

Identifiers

NCT03971656

STUDY00143484

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Control

No Intervention group

Description:

Standard care

Intervention

Experimental group

Description:

Three-Fold Nutritional Intervention

Treatment:

Behavioral: Education

Behavioral: Preoperative Dietitian Consult

Dietary Supplement: Nutritional Supplement