Fiber Formula Study Among Radiation Oncology Patients
Completed
Conditions studied: Constipation
In brief
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.
Key facts
- Study ID
- NCT00888147
- Run by
- Mayo Clinic
- People needed
- 19
- Starts
- 2009-04-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2011-09-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.