Optimal Tube Feeding Method in Head and Neck Cancer Patients
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
head and neck cancer, chemoradiation therapy, bolus feeding, gravity feeding, pump feeding, optimal enteral feeding method, To determine the optimal tube feeding method by analyzing percent weigtht loss., To determine the optimal tube feeding method by analyzing tolerance of enteral feeds., To determine the optimal tube feeding method by analyzing percent met of estimated calories and protein.
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bolus Type: Procedure
Name: Gravity Type: Procedure
Name: Pump Type: Device
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Charles A. Sammons Cancer Center at Baylor University Medical Center
Dallas, Texas, United States
Status: Not yet recruiting
Contact: Andreea Nguyen, MS in Nutrition - 214-794-0683 - andreea.nguyen@baylorhealth.edu
Charles A. Sammons Cancer Center at Baylor University Medical Center
Dallas, Texas, United States
Status: Not yet recruiting
Contact: Andreea Nguyen, MS in Nutrition - 214-794-0683 - andreea.nguyen@baylorhealth.edu
Start Date
July 2015
Completion Date
December 2015
Sponsors
Baylor Research Institute
Source
Baylor Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page