Preoperative Nutritional Intervention in Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2022-10-17

Brief Summary

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

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Detailed Description

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Conditions

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Head and Neck Cancer Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Three-Fold Nutritional Intervention

Group Type EXPERIMENTAL

Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

Oral nutritional supplementation

Preoperative Dietitian Consult

Intervention Type BEHAVIORAL

Nutritional assessment

Education

Intervention Type BEHAVIORAL

Informational materials about nutrition

Interventions

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Nutritional Supplement

Oral nutritional supplementation

Intervention Type DIETARY_SUPPLEMENT

Preoperative Dietitian Consult

Nutritional assessment

Intervention Type BEHAVIORAL

Education

Informational materials about nutrition

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No