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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus | Active Comparator | 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. |
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| Gravity | Active Comparator | 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. |
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| Pump | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus | Procedure | The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups). Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly. |
| Measure | Description | Time Frame |
|---|---|---|
| percent weight loss | 2 years | |
| tolerance of enteral feedings | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Percent met of estimated calories and proteins | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreea Nguyen, MS in Nutrition | Baylor Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles A. Sammons Cancer Center at Baylor University Medical Center | Dallas | Texas | 75246 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C073681 | NOP-bolus regimen |
| D006112 | Gravitation |
| ID | Term |
|---|---|
| D055580 | Astronomical Phenomena |
| D055585 | Physical Phenomena |
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| Gravity | Procedure | The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups). Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly. |
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| Pump | Device | The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups). Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly. |
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