Preoperative Nutritional Intervention in Head and Neck Cancer

NCT03971656 | Completed

• 1 other identifier: STUDY00143484
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer; Malnutrition

Keywords

Cancer; Surgery; Malnutrition; Preoperative; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

NO INTERVENTION

Standard care

Intervention

EXPERIMENTAL

Three-Fold Nutritional Intervention

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

Interventions

Nutritional Supplement DIETARY_SUPPLEMENT

Oral nutritional supplementation

Intervention

Preoperative Dietitian Consult BEHAVIORAL

Nutritional assessment

Intervention

Education BEHAVIORAL

Informational materials about nutrition

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Malnutrition; Neoplasms

Interventions

Dietary Supplements; Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 3, 2019
• Study Start: June 10, 2019
• Primary Completion: December 11, 2020
• Study Completion: October 17, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)