Fiber Formula Study Among Radiation Oncology Patients

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: Fiber containing tube feeding formula

• Registration Number: NCT00888147
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-23
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fiber formula	Fiber containing tube feeding formula	This group will receive tube feeding formula that contains fiber.

Primary Outcome Measures

Name	Time	Method
Whether each patient gets constipated.	Weekly for 2 weeks

Secondary Outcome Measures

Name	Time	Method
Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.	Weekly for 2 weeks

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States