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.
Eligible Conditions
- Myelodysplastic Syndrome
- Leukemia
Treatment Effectiveness
Phase-Based Effectiveness
Phase 3
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: 1 year
1 year
Admission frequency
Compliance
Bone Transplantation
Incidence of infections in each diet group
Incidence of major infections
Incidence of mucositis
Overall survival (OS)
Patient-Generated Subjective Global Assessment (PG-SGA)
Progression free survival (PFS)
Quality of life (QoL)
Symptom incidence
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2 Treatment Groups
Neutropenic Diet (Diet B)
1 of 2
Liberalized Hospital Diet (Diet A)
1 of 2
Active Control
470 Total Participants · 2 Treatment Groups
Primary Treatment: Neutropenic Diet (Diet B) · No Placebo Group · Phase 3
Neutropenic Diet (Diet B)
Other
ActiveComparator Group · 1 Intervention: Diet · Intervention Types: OtherLiberalized Hospital Diet (Diet A)
Other
ActiveComparator Group · 1 Intervention: Diet · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
University of FloridaLead Sponsor
1,274 Previous Clinical Trials
699,617 Total Patients Enrolled
Zeina A Al-Mansour, MDPrincipal InvestigatorUniversity of Florida
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer