Brain and Central Nervous System TumorsNCT00624962
Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors
A study testing nutritional intervention and therapeutic nutritional supplementation in people with Brain and Central Nervous System Tumors and Kidney Cancer, run by Vanderbilt University.
Trial summary
RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer. PURPOSE: This clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia
- What is being tested?
- nutritional intervention and therapeutic nutritional supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jan 2008
- Phase
- Interventional
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly confirmed diagnosis of 1 of the following:
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Sarcoma
- Any other stage IV solid tumor including:
- Wilms
Show all 13Show fewer
- Neuroblastoma
- Hepatoblastoma
- Any primary cancer of the central nervous system including:
- Cerebellar astrocytoma
- Medulloblastoma
- Ependymoma
- Spine tumors
Who cannot join
- No contraindication to enteral tube feeding including, but not limited to, any of the following:
- Gastrointestinal tract dysfunction (i.e., ileus, peritonitis, obstruction)
- Active sinusitis (can be waived for patients with gastrostomy tubes)
- Obstructive tumor in the nasopharynx
- PRIOR CONCURRENT THERAPY:
- No prior hematopoietic stem cell transplant
- All clinically indicated medications are permitted during the course of the study
- No other concurrent nutritional supplements
About this study
Official title: Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer.
PURPOSE: This clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or high-risk solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- To determine the feasibility and acceptance of undertaking early enteral tube feedings in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia or myelodysplastic syndromes, primary cancers of the central nervous system, or high-risk solid tumors.
Secondary
- To determine the safety of proactive enteral nutrition in these patients.
- To evaluate the effect of enteral nutrition on nutritional status in these patients.
OUTLINE: Patients have a small (6 or 8 French) nasogastral feeding tube or enterostomy tube inserted after diagnosis. Peptamen® AF tube feeding is administered via the enteral tube. Tube feedings are started as a continuous drip using an enteral feeding pump with a subsequent steady daily rate increase. Patients receive enteral feeding during courses 1-4 of chemotherapy.
- Conditions
- Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia, Liver Cancer, Neuroblastoma, Sarcoma
- Being tested
- nutritional intervention, therapeutic nutritional supplementation
- Keywords
- childhood soft tissue sarcoma, neuroblastoma, childhood hepatoblastoma, childhood cerebellar astrocytoma, childhood ependymoma, childhood brain stem glioma, childhood meningioma, childhood myelodysplastic syndromes, unspecified childhood solid tumor, protocol specific, childhood acute myeloid leukemia/other myeloid malignancies, central nervous system neoplasm, Wilms tumor and other childhood kidney tumors, childhood brain tumor, childhood medulloblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Kidney Neoplasms, Leukemia, Liver Neoplasms, Neuroblastoma, Sarcoma, Hepatoblastoma, Familial ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionDietary supplement
Also called Non indicated
Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy)
therapeutic nutritional supplementationDietary supplement
Also called not indicated
enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
| Study group | Role | What they receive |
|---|---|---|
| Correlative/Supportive Care | Other | Not described Receives: Dietary Supplement: nutritional intervention; Dietary Supplement: therapeutic nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days
Measured: 50% or more of the total nutritional support days.
Secondary outcomes (9)
Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period
Measured: twelve weeks
Number of times tubes replaced and number of subjects refusing replacement
Grade 3/4 gastrointestinal toxicity associated with enteral support
Complications associated with tube placement
Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level
Measured: Not indicated
Days of enteral (tube feeding) and total parenteral nutrition
Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy
Measured: week 12 or beginning course of Chemotherapy
Duration of hospitalization
Need for post-discharge nutritional support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startMar 2006
- Primary completionJan 2008 (estimated)
- Study completionJan 2008 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, John B. Pietsch, Vanderbilt University
- Investigators
- John B. Pietsch, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624962
- Sponsor's protocol ID
- CDR0000583517
- Other IDs
- VU-VICC-PED-0604, VU-VICC-060151
- Status last verified
- Nov 2010
- First submitted
- 27 Feb 2008
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
- ClinicalTrials.gov ID
- NCT00624962
- Acronym / sponsor ID
- CDR0000583517
- Conditions
- Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia, Liver Cancer, Neuroblastoma, Sarcoma
- Keywords
- childhood soft tissue sarcoma, neuroblastoma, childhood hepatoblastoma, childhood cerebellar astrocytoma, childhood ependymoma, childhood brain stem glioma, childhood meningioma, childhood myelodysplastic syndromes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Jan 2008 (estimated)
- First posted
- 28 Feb 2008 (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.
RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer.
PURPOSE: This clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or high-risk solid tumors.
Detailed description
OBJECTIVES:
Primary
- To determine the feasibility and acceptance of undertaking early enteral tube feedings in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia or myelodysplastic syndromes, primary cancers of the central nervous system, or high-risk solid tumors.
Secondary
- To determine the safety of proactive enteral nutrition in these patients.
- To evaluate the effect of enteral nutrition on nutritional status in these patients.
OUTLINE: Patients have a small (6 or 8 French) nasogastral feeding tube or enterostomy tube inserted after diagnosis. Peptamen® AF tube feeding is administered via the enteral tube. Tube feedings are started as a continuous drip using an enteral feeding pump with a subsequent steady daily rate increase. Patients receive enteral feeding during courses 1-4 of chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correlative/Supportive Care | Other | Dietary Supplement: nutritional intervention, Dietary Supplement: therapeutic nutritional supplementation |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Newly confirmed diagnosis of 1 of the following:
Key exclusion criteria (8 listed)
- No contraindication to enteral tube feeding including, but not limited to, any of the following:
- No prior hematopoietic stem cell transplant
- All clinically indicated medications are permitted during the course of the study
- No other concurrent nutritional supplements
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 |
|---|---|---|
| nutritional interventionAlso: Non indicatedNutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy) | Dietary supplement | Correlative/Supportive Care |
| therapeutic nutritional supplementationAlso: not indicatedenteral feedings via a nasogastric tube for 50% or more of the total nutritional support days. | Dietary supplement | Correlative/Supportive Care |
Primary outcome
Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days
Time frame: 50% or more of the total nutritional support days.
9 secondary outcomes
Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period
Time frame: twelve weeks
Number of times tubes replaced and number of subjects refusing replacement
Grade 3/4 gastrointestinal toxicity associated with enteral support
Complications associated with tube placement
Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level
Time frame: Not indicated
Days of enteral (tube feeding) and total parenteral nutrition
Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy
Time frame: week 12 or beginning course of Chemotherapy
Duration of hospitalization
Need for post-discharge nutritional support
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
John B. Pietsch, MD study chair
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention and therapeutic nutritional supplementation in people with Brain and Central Nervous System Tumors and Kidney Cancer, run by Vanderbilt University.
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 13 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days (time frame: 50% or more of the total nutritional support days.). 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 11 Dec 2014.