Fiber Formula Study Among Radiation Oncology Patients

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?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00888147

Enrollment

Registered

2009-04-27

Start date

2009-04-30

Completion date

2011-07-31

Last updated

2011-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

Tube feeding, Fiber, Constipation

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.

Interventions

DIETARY_SUPPLEMENTFiber containing tube feeding formula

This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Whether each patient gets constipated.	Weekly for 2 weeks

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026