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Fiber Formula Study Among Radiation Oncology Patients

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ClinicalTrials.gov Identifier: NCT00888147
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : September 26, 2011
Sponsor:
Information provided by (Responsible Party):
Lisa Epp, 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.


Condition or disease Intervention/treatment
Constipation Dietary Supplement: Fiber containing tube feeding formula

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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?"
Study Start Date : April 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Fiber formula
This group will receive tube feeding formula that contains fiber.
Dietary Supplement: Fiber containing tube feeding formula
This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.
Other Name: There is no brand name we are using. We will use the formula that best meets the patient calorie, protein and fluid needs.



Primary Outcome Measures :
  1. Whether each patient gets constipated. [ Time Frame: Weekly for 2 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
These participants have head and neck cancer, are undergoing radiaiton therapy and will have a percutaneous endoscopic gastrostomy (PEG) placed.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888147


Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Lisa M Epp, BS Mayo Clinic
Study Director: Yolanda I Garces, MD Mayo Clinic

Responsible Party: Lisa Epp, Home Enteral Nutrition Coordinator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00888147     History of Changes
Other Study ID Numbers: 08-005304
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011

Keywords provided by Lisa Epp, Mayo Clinic:
Tube feeding
Fiber
Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms