Clinical trial NCT01536782: Optimal Tube Feeding Method in Head and Neck Cancer Patients
Official title: The Optimal Tube Feeding Method in Head and Neck Cancer Patients: A Comparison Between Bolus, Gravity, and Tube Feeding Pump.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
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.
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2012-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: percent weight loss
timeFrame: 2 years
measure: tolerance of enteral feedings
timeFrame: 2 Years
Secondary outcomes:
measure: Percent met of estimated calories and proteins
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center at Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Andreea Nguyen, MS in Nutrition
role: PRINCIPAL_INVESTIGATOR
References: