Acute Myeloid LeukemiaPhase 2NCT03108911
Gluten Free Diet in Diminishing Side Effects Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
A Phase 2 study testing Best Practice, Biospecimen Collection and Dietary Intervention in people with Acute Myeloid Leukemia, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This randomized phase II trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Best Practice, Biospecimen Collection and Dietary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 14 Nov 2017
- Phase
- Phase 2
- 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
Who may be able to join
- Patients undergoing AML induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen
- No history of celiac disease or non-celiac gluten sensitivity
- No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening
- No documented bacteremia at time of initial screening
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at time of initial screening
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy
This randomized phase II trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard diet.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if a gluten free diet (GFD) modulates the rate and severity of bacteremia and gastrointestinal toxicity (measured by total parenteral nutrition [TPN] or nothing by mouth [NPO] order) in patients undergoing standard acute myeloid leukemia (AML) induction chemotherapy.
SECONDARY OBJECTIVES:
- To determine the tolerance of, and compliance with, a GFD in patients undergoing standard AML induction chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
GROUP II: Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Best Practice, Biospecimen Collection, Dietary Intervention, Laboratory Biomarker Analysis
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard diet
Biospecimen CollectionProcedure or surgery
Provide stool sample
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive GFD
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (GFD) | Experimental | Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis. Receives: Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Laboratory Biomarker Analysis |
| Group II (standard diet) | Experimental | Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and severity of bacteremia with enteric organisms during AML induction therapy assessed using stool samples
To determine how often patients develop bacteremia during AML induction therapy
Measured: Up to 30 days
Rate and severity of GI symptoms during AML induction therapy
To determine what the severity is if GI symptoms develops
Measured: Up to 30 days
Rate of compliance with GFD assessed using daily food intake diary
Adherence to diet will be recorded in a food diary. Compliance will be defined as > 67% of meals being gluten free.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start27 Jul 2017
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Why it stopped: limited resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roger Strair, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108911
- Sponsor's protocol ID
- 021702
- Other IDs
- NCI-2017-00498, 021702, P30CA072720
- Status last verified
- Nov 2017
- First submitted
- 6 Apr 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT03108911
- Acronym / sponsor ID
- 021702
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: limited resources
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
This randomized phase II trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard diet.
Detailed description
PRIMARY OBJECTIVES:
- To determine if a gluten free diet (GFD) modulates the rate and severity of bacteremia and gastrointestinal toxicity (measured by total parenteral nutrition [TPN] or nothing by mouth [NPO] order) in patients undergoing standard acute myeloid leukemia (AML) induction chemotherapy.
SECONDARY OBJECTIVES:
- To determine the tolerance of, and compliance with, a GFD in patients undergoing standard AML induction chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
GROUP II: Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (GFD) | Experimental | Procedure: Biospecimen Collection, Other: Dietary Intervention, Other: Laboratory Biomarker AnalysisPatients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis. |
| Group II (standard diet) | Experimental | Other: Best Practice, Procedure: Biospecimen Collection, Other: Laboratory Biomarker AnalysisPatients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing AML induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen
- No history of celiac disease or non-celiac gluten sensitivity
- No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening
- No documented bacteremia at time of initial screening
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at time of initial screening
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard diet | Other | Group II (standard diet) |
| Biospecimen CollectionProvide stool sample | Procedure or surgery | Group I (GFD), Group II (standard diet) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive GFD | Other | Group I (GFD) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (GFD), Group II (standard diet) |
Primary outcome
Rate and severity of bacteremia with enteric organisms during AML induction therapy assessed using stool samples
Time frame: Up to 30 days
To determine how often patients develop bacteremia during AML induction therapy
Rate and severity of GI symptoms during AML induction therapy
Time frame: Up to 30 days
To determine what the severity is if GI symptoms develops
Rate of compliance with GFD assessed using daily food intake diary
Time frame: Up to 30 days
Adherence to diet will be recorded in a food diary. Compliance will be defined as > 67% of meals being gluten free.
Results and safety
The study was stopped early (reason given: limited resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 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.
Roger Strair principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice, Biospecimen Collection and Dietary Intervention in people with Acute Myeloid Leukemia, run by Rutgers, The State University of New Jersey 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Nov 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: limited resources). Results are not available in the source record.
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?
Rate and severity of bacteremia with enteric organisms during AML induction therapy assessed using stool samples (time frame: Up to 30 days). The study lists 3 primary outcomes in all. 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 17 Nov 2017.