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.
|Study Design:||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?"|
- Whether each patient gets constipated. [ Time Frame: Weekly for 2 weeks ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||April 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888147
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Lisa M Epp, BS||Mayo Clinic|
|Study Director:||Yolanda I Garces, MD||Mayo Clinic|