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The Optimal Tube Feeding Method in Head and Neck Cancer Patients: A Comparison Between Bolus, Gravity, and Tube Feeding Pump.


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 CenterDallas, Texas  75246