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Diet Comparison for Leukemia
Phase 3
Waitlist Available
Led By Zeina A Al-Mansour, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Acute lymphoblastic leukemia (ALL) receiving an intensive induction chemotherapy (e.g., HyperCVAD±R, CALGB9251, Larsons protocol) with an expected duration of neutropenia of ≥7 days; OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare the safety of a diet with fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia.
Who is the study for?
This trial is for adults with acute leukemia or myelodysplastic syndrome undergoing intensive chemotherapy or stem cell transplant, expecting neutropenia (low white blood cell count) for 7+ days. It's not for those with active infections, uncontrolled fungal/HIV/Hepatitis B/C infections, on tube/parenteral nutrition, managed as outpatients during neutropenia, or unwilling to eat fresh produce.Check my eligibility
What is being tested?
The study compares the safety of a liberalized hospital diet that includes fresh fruits and vegetables against a strict neutropenic diet in patients with prolonged neutropenia. Both diets follow FDA food safety guidelines.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects are not typical as seen in drug trials. However, there may be risks related to potential infection from consuming fresh produce while having low immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have ALL and am on a strong chemotherapy plan expected to lower my white blood cells for 7+ days.
Select...
I am receiving initial or repeat chemotherapy for AML or MDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of major infections
Secondary outcome measures
Admission frequency
Compliance
Bone Transplantation
+7 moreTrial Design
2Treatment groups
Active Control
Group I: Liberalized Hospital Diet (Diet A)Active Control1 Intervention
Diet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables.
Group II: Neutropenic Diet (Diet B)Active Control1 Intervention
Diet B is the hospital neutropenic diet.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,488 Total Patients Enrolled
11 Trials studying Leukemia
326 Patients Enrolled for Leukemia
Zeina A Al-Mansour, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any untreated major infections.I haven't taken antibiotics for infections in the last 7 days.I have ALL and am on a strong chemotherapy plan expected to lower my white blood cells for 7+ days.I am 18 years old or older.I am undergoing a stem cell transplant that requires a hospital stay due to expected neutropenia.I am receiving initial or repeat chemotherapy for AML or MDS.I am unwilling to eat fresh fruit or vegetables.I do not have uncontrolled HIV or Hepatitis B/C.I do not have an uncontrolled fungal infection.I am receiving my nutrition through a feeding tube or IV.I am currently receiving treatment for blood cancer or a stem cell transplant.My low white blood cell count will be managed outside the hospital.I have a condition that does not require a stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Liberalized Hospital Diet (Diet A)
- Group 2: Neutropenic Diet (Diet B)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Diet B for cancer patients with low white blood cell counts?
"Since this is a Phase 3 trial, there is some data indicating that this diet is effective, and there have been multiple rounds of data supporting its safety, our team at Power has rated the safety of the Neutropenic Diet (Diet B) as a 3."
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