ConstipationNCT00888147
Fiber Formula Study Among Radiation Oncology Patients
An observational study of Constipation, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Fiber containing tube feeding formula
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These participants have head and neck cancer, are undergoing radiaiton therapy and will have a percutaneous endoscopic gastrostomy (PEG) placed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?"
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
- Being tested
- Fiber containing tube feeding formula
- Keywords
- Tube feeding, Fiber, Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber containing tube feeding formulaDietary supplement
Also called There is no brand name we are using. We will use the formula that best meets the patient calorie, protein and fluid needs.
This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.
| Study group | Role | What they receive |
|---|---|---|
| Fiber formula | This group will receive tube feeding formula that contains fiber. Receives: Dietary Supplement: Fiber containing tube feeding formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether each patient gets constipated.
Measured: 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.
Measured: Weekly for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Epp, Mayo Clinic
- Investigators
- Lisa M Epp, BS, Principal investigator, Mayo ClinicYolanda I Garces, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888147
- Sponsor's protocol ID
- 08-005304
- Status last verified
- Sep 2011
- First submitted
- 24 Apr 2009
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?"
- ClinicalTrials.gov ID
- NCT00888147
- Acronym / sponsor ID
- 08-005304
- Conditions
- Constipation
- Keywords
- Tube feeding, Fiber, Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fiber formula | – | Dietary Supplement: Fiber containing tube feeding formulaThis group will receive tube feeding formula that contains fiber. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These participants have head and neck cancer, are undergoing radiaiton therapy and will have a percutaneous endoscopic gastrostomy (PEG) placed.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber containing tube feeding formulaAlso: There is no brand name we are using. We will use the formula that best meets the patient calorie, protein and fluid needs.This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber. | Dietary supplement | Fiber formula |
Primary outcome
Whether each patient gets constipated.
Time frame: Weekly for 2 weeks
1 secondary outcome
Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.
Time frame: Weekly for 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Epp, BS principal investigator
Mayo Clinic
Yolanda I Garces, MD study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether each patient gets constipated. (time frame: Weekly for 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011.