Acute Lymphoblastic LeukemiaNCT00726934
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
A study testing Food Safety Guidelines and Neutropenic Diet in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Indiana University at 6 sites in United States.
Trial summary
The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma
- What is being tested?
- Food Safety Guidelines and Neutropenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2007to Jan 2017
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 1 and 30 years with:
- Acute lymphoblastic leukemia/lymphoma
- Malignant brain tumor
- Non-CNS solid tumors
- Acute myeloblastic leukemia
- Non-Hodgkin's lymphoma Hodgkin's disease
- Head and Neck tumors
- Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least 70% of the time OR has a risk of febrile neutropenia of at least 20%. This can be any cycle number, it does NOT need to be the FIRST cycle of chemotherapy they are to receive.
Who cannot join
- Patients receiving myeloablative chemotherapy in preparation for allogeneic or autologous bone marrow or stem cell transplant.
- Co-morbidity with immunosuppressive disease such as AIDS.
- Asplenia.
- Patients with documented infection at time of enrollment.
- Patients who are not fed orally (G-tube dependant, TPN-dependant).
- Patients actively receiving radiation to the brain or gastrointestinal tract for sarcoma.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
NYU Langone Medical Center
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Rady Children's Hospital San Diego
San Diego, California, 92123
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients.
Read the detailed description
Historically, many interventions have been tried to reduce the incidence of infection by reducing patients' exposures to potential pathogens. The neutropenic diet is one such intervention that was intended to reduce the introduction of bacteria into the host's gastrointestinal tract. This diet excludes foods considered to be high risk for bacterial colonization, especially raw fruits and vegetables. The only studies evaluating this diet have used this intervention in combination with germ free environments, which have been phased out of practice, and the independent effect of this diet remains unknown. In addition, pediatric oncology patients suffer significant gastrointestinal side effects secondary to cancer therapy, which are likely to affect their satisfaction with this dietary regimen. Qualitative data in these children suggests that decreased pleasure from food is a major concern for them and preliminary data on the neutropenic diet showed that although patients were able to stick to it, they found it difficult. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) offer more liberalized food safety guidelines for immunocompromised patients. We hypothesize that the neutropenic dietary restrictions offer no advantage over the FDA and CDC endorsed food safety guidelines and that the food safety guidelines will afford patients an improved quality of life through increased choice and control over their diet. The results of this study could potentially modify clinical practice to improve the quality of life of these patients without adverse effects on their rate of infection. Furthermore, the allowance of fresh fruits and vegetables back into the diets of these patients may have a positive impact on their health.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma, Sarcoma, Neuroblastoma
- Being tested
- Food Safety Guidelines, Neutropenic Diet
- Keywords
- Neutropenic Diet, Food Safety Guidelines, child, cancer
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Sarcoma, Neuroblastoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Safety GuidelinesOther
Also called Food Safety Diet, FDA Food Safety Guidelines
Participants will be randomized to the food safety guidelines will receive information and recommendations regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food.
Neutropenic DietOther
Also called Low Bacteria Diet
The Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations:
- Avoid raw vegetables and fruit (Oranges and bananas are okay.)
- Avoid take-out foods and fast foods and fountain drinks.
- Avoid aged cheese (blue, Roquefort, Brie).
- Cook all produce to well done. Eggs must be hard-boiled.
- Avoid deli meats.
- No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store.
- No well water
- No yogurt
| Study group | Role | What they receive |
|---|---|---|
| Neutropenic Diet | Active comparator | Participants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study. Receives: Other: Food Safety Guidelines; Other: Neutropenic Diet |
| FDA Food Safety Guidelines | Active comparator | Participants will be instructed to follow the FDA Food Safety Guidelines Receives: Other: Food Safety Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutropenic Infection
Measured: approximately 4 weeks
Secondary outcomes (2)
Documented Infection
Measured: approximately 4 weeks
Quality of life
Measured: Baseline and at study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Moody, Indiana University
- Investigators
- Karen Moody, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726934
- Sponsor's protocol ID
- 06-08-367
- Status last verified
- Feb 2017
- First submitted
- 30 Jul 2008
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT00726934
- Acronym / sponsor ID
- 06-08-367
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma, Sarcoma, Neuroblastoma
- Keywords
- Neutropenic Diet, Food Safety Guidelines, child, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Aug 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.
The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients.
Detailed description
Historically, many interventions have been tried to reduce the incidence of infection by reducing patients' exposures to potential pathogens. The neutropenic diet is one such intervention that was intended to reduce the introduction of bacteria into the host's gastrointestinal tract. This diet excludes foods considered to be high risk for bacterial colonization, especially raw fruits and vegetables. The only studies evaluating this diet have used this intervention in combination with germ free environments, which have been phased out of practice, and the independent effect of this diet remains unknown. In addition, pediatric oncology patients suffer significant gastrointestinal side effects secondary to cancer therapy, which are likely to affect their satisfaction with this dietary regimen. Qualitative data in these children suggests that decreased pleasure from food is a major concern for them and preliminary data on the neutropenic diet showed that although patients were able to stick to it, they found it difficult. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) offer more liberalized food safety guidelines for immunocompromised patients. We hypothesize that the neutropenic dietary restrictions offer no advantage over the FDA and CDC endorsed food safety guidelines and that the food safety guidelines will afford patients an improved quality of life through increased choice and control over their diet. The results of this study could potentially modify clinical practice to improve the quality of life of these patients without adverse effects on their rate of infection. Furthermore, the allowance of fresh fruits and vegetables back into the diets of these patients may have a positive impact on their health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutropenic Diet | Active comparator | Other: Food Safety Guidelines, Other: Neutropenic DietParticipants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study. |
| FDA Food Safety Guidelines | Active comparator | Other: Food Safety GuidelinesParticipants will be instructed to follow the FDA Food Safety Guidelines |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients between the ages of 1 and 30 years with:
- Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least 70% of the time OR has a risk of febrile neutropenia of at least 20%. This can be any cycle number, it does NOT need to be the FIRST cycle of chemotherapy they are to receive.
Key exclusion criteria (6 listed)
- Patients receiving myeloablative chemotherapy in preparation for allogeneic or autologous bone marrow or stem cell transplant.
- Co-morbidity with immunosuppressive disease such as AIDS.
- Asplenia.
- Patients with documented infection at time of enrollment.
- Patients who are not fed orally (G-tube dependant, TPN-dependant).
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 |
|---|---|---|
| Food Safety GuidelinesAlso: Food Safety Diet, FDA Food Safety GuidelinesParticipants will be randomized to the food safety guidelines will receive information and recommendations regarding Food Shopping, Food Storage, Food Preparation, Safe Cooking, and Safe Serving of Food. | Other | FDA Food Safety Guidelines, Neutropenic Diet |
| Neutropenic DietAlso: Low Bacteria DietThe Neutropenic Diet Guideline includes all information contained in the FDA Food Safety Guidelines with the addition of the following recommendations: 1. Avoid raw vegetables and fruit (Oranges and bananas are okay.) 2. Avoid take-out foods and fast foods and fountain drinks. 3. Avoid aged cheese (blue, Roquefort, Brie). 4. Cook all produce to well done. Eggs must be hard-boiled. 5. Avoid deli meats. 6. No raw nuts, nuts roasted in shell, or freshly ground nut butters from a health food store. 7. No well water 8. No yogurt | Other | Neutropenic Diet |
Primary outcome
Neutropenic Infection
Time frame: approximately 4 weeks
2 secondary outcomes
Documented Infection
Time frame: approximately 4 weeks
Quality of life
Time frame: Baseline and at study end
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 8 Feb 2017.
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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.
Karen Moody, MD, MS principal investigator
Indiana University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Safety Guidelines and Neutropenic Diet in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Indiana University at 6 sites 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 8 inclusion and 6 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Neutropenic Infection (time frame: approximately 4 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 8 Feb 2017.