Preoperative Nutritional Intervention in Head and Neck Cancer

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Malnutrition
• Interventions: Dietary Supplement: Nutritional Supplement; Behavioral: Preoperative Dietitian Consult; Behavioral: Education

• Registration Number: NCT03971656
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2019-06-10
• Primary Completion: 2020-12-11
• Study Completion: 2022-10-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Preoperative Dietitian Consult	Three-Fold Nutritional Intervention
Intervention	Nutritional Supplement	Three-Fold Nutritional Intervention
Intervention	Education	Three-Fold Nutritional Intervention

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States