The Optimal Tube Feeding Method in Head and Neck Cancer Patients: A Comparison Between Bolus, Gravity, and Tube Feeding Pump.
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
The Optimal Tube Feeding Method in Head and Neck Cancer Patients: A Comparison Between Bolus, Gravity, and Tube Feeding Pump.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
percent weight loss
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Andreea Nguyen, MS in Nutrition
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor Health Care System
Authority:
United States: Institutional Review Board
Study ID:
012-026
NCT ID:
NCT01536782
Start Date:
February 2014
Completion Date:
February 2015
Related Keywords:
- Head and Neck Cancer
- 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.
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Charles A. Sammons Cancer Center at Baylor University Medical Center | Dallas, Texas 75246 |
