Fiber Formula Study Among Radiation Oncology Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lisa Epp, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00888147
First received: April 24, 2009
Last updated: September 23, 2011
Last verified: September 2011

April 24, 2009
September 23, 2011
April 2009
July 2011   (final data collection date for primary outcome measure)
Whether each patient gets constipated. [ Time Frame: Weekly for 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00888147 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
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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?"

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

These participants have head and neck cancer, are undergoing radiaiton therapy and will have a percutaneous endoscopic gastrostomy (PEG) placed.

Constipation
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.
Fiber formula
This group will receive tube feeding formula that contains fiber.
Intervention: Dietary Supplement: Fiber containing tube feeding formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00888147
08-005304
Yes
Lisa Epp, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Lisa M Epp, BS Mayo Clinic
Study Director: Yolanda I Garces, MD Mayo Clinic
Mayo Clinic
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP