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OpenTrials
Completed

NCT Number: NCT03971656

Preoperative Nutritional Intervention in Head and Neck Cancer

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Supplement

Dietary Supplement

Oral nutritional supplementation

Preoperative Dietitian Consult

Behavioral

Nutritional assessment

Education

Behavioral

Informational materials about nutrition

Primary outcomes

  1. Change in Scored Patient-Generated Subjective Global Assessment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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