Optimal Tube Feeding Method in Head and Neck Cancer Patients

NCT01536782 | Withdrawn

• 1 other identifier: 012-026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (2)

• percent weight loss

  2 years

• tolerance of enteral feedings

  2 Years

Secondary Outcomes (1)

• Percent met of estimated calories and proteins

  2 years

Study Arms (3)

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.

Procedure: Bolus

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.

Procedure: Gravity

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.

Device: Pump

Interventions

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.

Bolus

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.

Gravity

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.

Pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• years or older
• Diagnosis of SCCHN undergoing concurrent chemoradiation therapy (including patients who received induction therapy upfront

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Charles A. Sammons Cancer Center at Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

NOP-bolus regimen; Gravitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Astronomical Phenomena; Physical Phenomena

Study Officials

• Andreea Nguyen, MS in Nutrition

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: February 22, 2012
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 29, 2026

Record last verified: 2019-05

Locations

US (1)