Status:
COMPLETED
Fiber Formula Study Among Radiation Oncology Patients
Lead Sponsor:
Mayo Clinic
Conditions:
Constipation
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00888147
Start Date
April 1 2009
End Date
July 1 2011
Last Update
September 26 2011
Active Locations (1)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905