Fiber Formula Study Among Radiation Oncology Patients

NCT00888147 | Completed DMC

• 1 other identifier: 08-005304
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Tube feeding; Fiber; Constipation

Outcome Measures

Primary Outcomes (1)

• Whether each patient gets constipated.

  Weekly for 2 weeks

Secondary Outcomes (1)

• Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.

  Weekly for 2 weeks

Study Arms (1)

Fiber formula

This group will receive tube feeding formula that contains fiber.

Dietary Supplement: Fiber containing tube feeding formula

Interventions

Fiber containing tube feeding formula DIETARY_SUPPLEMENT

This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.

Also known as: There is no brand name we are using. We will use the formula that best meets the patient calorie, protein and fluid needs.

Fiber formula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Proteins

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Lisa M Epp, BS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Yolanda I Garces, MD

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Home Enteral Nutrition Coordinator

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 27, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

US (1)