We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimal Tube Feeding Method in Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01536782
Recruitment Status : Suspended (PI left the company)
First Posted : February 22, 2012
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Head and Neck Cancer Procedure: Bolus Procedure: Gravity Device: Pump

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Optimal Tube Feeding Method in Head and Neck Cancer Patients: A Comparison Between Bolus, Gravity, and Tube Feeding Pump.
Actual Study Start Date : February 2015
Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Bolus
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.
Procedure: Bolus

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.

Active Comparator: Gravity
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.
Procedure: Gravity

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.

Active Comparator: Pump
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.
Device: Pump

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.



Outcome Measures

Primary Outcome Measures :
  1. percent weight loss [ Time Frame: 2 years ]
  2. tolerance of enteral feedings [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. Percent met of estimated calories and proteins [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536782


Locations
United States, Texas
Charles A. Sammons Cancer Center at Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Andreea Nguyen, MS in Nutrition Baylor Health Care System
More Information

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01536782     History of Changes
Other Study ID Numbers: 012-026
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Baylor Research Institute:
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.

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms