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Completed

NCT Number: NCT00888147

Fiber Formula Study Among Radiation Oncology Patients

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiber containing tube feeding formula

Dietary Supplement

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

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.

Primary outcomes

  1. Whether each patient gets constipated.

    Time frame: Weekly for 2 weeks

Secondary outcomes

  1. Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.

    Time frame: Weekly for 2 weeks

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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?"

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2009
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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