Clinical trial NCT00888147: Fiber Formula Study Among Radiation Oncology Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: Tube feeding
Fiber
Constipation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: These participants have head and neck cancer, are undergoing radiaiton therapy and will have a percutaneous endoscopic gastrostomy (PEG) placed.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Whether each patient gets constipated.
timeFrame: Weekly for 2 weeks
Secondary outcomes:
measure: Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.
timeFrame: Weekly for 2 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lisa M Epp, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Yolanda I Garces, MD
role: STUDY_DIRECTOR
References: