Fiber Formula Study Among Radiation Oncology Patients

Constipation Clinical Trial

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?"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888147
• Other study ID #: 08-005304
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: September 23, 2011
• Start date: April 2009
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Fiber containing tube feeding formula
This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether each patient gets constipated.		Weekly for 2 weeks	Yes
Secondary	Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.		Weekly for 2 weeks	Yes