Optimal Tube Feeding Method in Head and Neck Cancer Patients

Baylor Scott and White Health (BSWH)

Status: Terminated

Conditions: Head and Neck Cancer

Treatments: Device: Pump; Procedure: Gravity; Procedure: Bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT01536782

012-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Bolus

Active Comparator group

Description:

Upon tube feeding initiation determined by the HNC multidisciplinary team, the patients will be randomized into three different groups, each consisting of 20 patients each: Bolus (Group 1), Gravity (Group 2), and Pump (Group 3). The randomization process within these three groups will based on 1) age and 2) estimated caloric need. For example, if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either Bolus, Gravity or Pump group. Another example is that if we have two 45-year-old patients whose estimated needs are 2400kcals/day, then one patient will randomly be assigned to the Bolus group, and the other one will be randomly assigned to the Gravity group. The third patient that will fit that category will be assigned to the Pump group.

Treatment:

Procedure: Bolus

Gravity

Active Comparator group

Description:

Upon tube feeding initiation determined by the HNC multidisciplinary team, the patients will be randomized into three different groups, each consisting of 20 patients each: Bolus (Group 1), Gravity (Group 2), and Pump (Group 3). The randomization process within these three groups will based on 1) age and 2) estimated caloric need. For example, if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either Bolus, Gravity or Pump group. Another example is that if we have two 45-year-old patients whose estimated needs are 2400kcals/day, then one patient will randomly be assigned to the Bolus group, and the other one will be randomly assigned to the Gravity group. The third patient that will fit that category will be assigned to the Pump group.

Treatment:

Procedure: Gravity

Pump

Active Comparator group

Description:

Upon tube feeding initiation determined by the HNC multidisciplinary team, the patients will be randomized into three different groups, each consisting of 20 patients each: Bolus (Group 1), Gravity (Group 2), and Pump (Group 3). The randomization process within these three groups will based on 1) age and 2) estimated caloric need. For example, if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either Bolus, Gravity or Pump group. Another example is that if we have two 45-year-old patients whose estimated needs are 2400kcals/day, then one patient will randomly be assigned to the Bolus group, and the other one will be randomly assigned to the Gravity group. The third patient that will fit that category will be assigned to the Pump group.

Treatment:

Device: Pump