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
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|
|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|
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.
- Whether each patient gets constipated. [ Time Frame: Weekly for 2 weeks ]
- 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 ]
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
|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|