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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?"


N/A
18 Years
N/A
Not Enrolling
Both
Constipation

Thank you

Trial Information

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?"


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Whether each patient gets constipated.

Outcome Time Frame:

Weekly for 2 weeks

Safety Issue:

Yes

Principal Investigator

Lisa M Epp, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

08-005304

NCT ID:

NCT00888147

Start Date:

April 2009

Completion Date:

July 2011

Related Keywords:

  • Constipation
  • Tube feeding
  • Fiber
  • Constipation
  • Constipation

Name

Location

Mayo Clinic RochesterRochester, Minnesota  55905