Fiber Formula Study Among Radiation Oncology Patients

Study Overview
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Brief Summary
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During radiation treatment for head and neck cancer a large percentage of patients at Mayo Clinic Rochester develop the need for tube feeding to meet nutrition and hydration needs. These patients are usually taking pain medication along with a stool softener or laxative. Currently, when these patients get a feeding tube it is our standard practice to choose a fiber-free enteral tube feeding formula as to not worsen their constipation. Currently, there are no guidelines as to which patients are good candidates for fiber containing enteral tube feeding formulas. The investigators hope this study will help determine if fiber containing enteral tube feeding formulas can be used for patients undergoing radiation for head and neck cancer without increasing rates of constipation or increasing use of stool softeners/laxatives. Hypothesis: Participants enrolled in the study will not have increased rates of constipation on fiber-containing enteral tube feeding formula compared to historical standards on fiber-free formula.

Official Title
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Pilot Study: Does Using a Fiber Containing Enteral Tube Feeding Formula Increase Constipation and the Use of Stool Softeners in Patients Undergoing Radiation Therapy and Have a Percutaneous Endoscopic Gastrostomy (PEG) Placed?

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Fiber containing tube feeding formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer of: 1) lip/oral cavity 2) pharynx 3) larynx 4) nasal cavity/paranasal sinus 5) salivary gland 6) Thyroid according to AJCC cancer staging manual 6th edition 2002 Current radiation therapy or starting radiation therapy in the next 2 weeks Patient must have a gastrostomy tube Exclusion Criteria: Jejunostomy tube Diagnosis of Irritable Bowel Syndrome (abdominal pain and diarrhea or constipation lasting at least three months in one year) Short bowel (A patient is generally considered to have short bowel syndrome when less than 100 to 150 centimeters of functioning small bowel remains) Body max index (BMI) <18.5kg/m2 Gastroparesis (when the stomach retains food for longer than normal periods). This must be diagnosed with a gastric emptying study. Use of Metoclopramide Receiving 5-FU chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fiber formula<br>This group will receive tube feeding formula that contains fiber. | Dietary Supplement: Fiber containing tube feeding formula<br>* This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.<br>* Other names: There is no brand name we are using. We will use the formula that best meets the patient calorie, protein and fluid needs.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether each patient gets constipated. |  | Weekly for 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient. |  | Weekly for 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tube feeding, Fiber, Constipation