Optimal Tube Feeding Method in Head and Neck Cancer Patients

Not Applicable

Terminated

• Conditions: Head and Neck Cancer

• Registration Number: NCT01536782
• Lead Sponsor: Baylor Research Institute

Brief Summary

The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.

Detailed Description

It is a great challenge to maintain the nutritional status of the head and neck cancer (HNC) patients through treatment advances such as combined chemoradiation therapy or CRT. For all these reasons, HNC patients undergoing treatment, frequently require alternate methods of nutrition support such as as enteral tube feeding via a gastrostomy tube.Upon gastric tube feeding initiation, the registered dietitian (RD) must consider the three different methods: bolus (using a syringe), gravity (using gravity feeding bags), and pump (using a tube feeding pump).

Typically, patients are started on bolus (OPTION A), changed to gravity (OPTION B) if bolus feeds are not tolerated, and ultimately changed to pump (OPTION C) if gravity feeds are not tolerated. The concern is that in this process of starting with OPTION A, and moving to OPTION B or further to OPTION C, the patient may experience unintentional weight loss and dehydration related to tube feeding intolerance and/or tube feeding inadequacy. Consequently, this places the patient at risk of, but not limited to, hospital admission for dehydration and/or malnutrition, and treatment interruption. Therefore, exploring the idea of an optimal feeding method and starting patients on it from the beginning, may improve patient outcomes in terms of nutritional status.

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-02-20
• Study First Posted: 2012-02-22
• Study Start: 2015-02
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males and females
• 18 years or older
• Diagnosis of SCCHN undergoing concurrent chemoradiation therapy (including patients who received induction therapy upfront

Exclusion Criteria

• Patients who have a small bowel feeding tube (only tube feeding via pump is allowed in this case)
• Patients with history of gastric surgery which may have resulted in altered gastrointestinal function
• Patients with history of uncontrolled diabetes and/or gastroparesis which may interfere with gastric emptying and inability to tolerate bolus feeds
• Patients at high risk of aspiration in which case slower feeds by using gravity or pump are indicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
tolerance of enteral feedings	2 Years
percent weight loss	2 years

Secondary Outcome Measures

Name	Time	Method
Percent met of estimated calories and proteins	2 years

Trial Locations

Locations (1)

Charles A. Sammons Cancer Center at Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States