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NCT03971656 Clinical Trial

Preoperative Nutritional Intervention in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Preoperative Nutritional Intervention in Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03971656
Other study ID # STUDY00143484
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2019
Est. completion date October 17, 2022

Study information
Verified date September 2023
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date October 17, 2022
Est. primary completion date December 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Nutritional Supplement
Oral nutritional supplementation
Behavioral:
• Preoperative Dietitian Consult
Nutritional assessment
• Education
Informational materials about nutrition

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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