Back to resultsComparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)
Primary Purpose
Leukemia, Myelodysplastic Syndromes
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by
About this trial
This is an interventional supportive care trial for Leukemia focused on measuring leukemia, myelodysplastic, myeloid, lymphoblastic, diet, infection, hematopoietic, stem cell, transplant
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Undergoing treatment for hematologic malignancies or HSCT as outlined below:
- Underlying diagnosis for non-HSCT patients:
- Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or reinduction chemotherapy; OR
- 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
- Allogeneic or autologous HSCT for any indication. For patients undergoing reduced intensity conditioning, only those regimens in which the expected neutropenia is ≥ 7 days are permitted and the patient must reside in the hospital
- Expected duration of neutropenia of ≥ 7 days
Exclusion Criteria:
- Use of anti infectives for treatment of active systemic infections within 7 days prior to initiation of study diet
- Untreated major infection at presentation
- Patients with uncontrolled invasive fungal infection (defined as those who have not completed at least 6 weeks of treatment; or who are symptomatic with two CT scans, at least 1 week apart showing uncontrolled disease at the time of initiation of study diet)
- Uncontrolled HIV, Hepatitis B and C infection
- Receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment
- Patients unwilling to eat fresh fruit and/or vegetables
- Planned management of neutropenia in the outpatient setting
Sites / Locations
- UF Health Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Liberalized Hospital Diet (Diet A)
Neutropenic Diet (Diet B)
Arm Description
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.
Diet B is the hospital neutropenic diet.
Outcomes
Primary Outcome Measures
Incidence of major infections
The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.
Secondary Outcome Measures
Incidence of infections in each diet group
This secondary objective of the trial is to compare the impact of diet on severe infections including: septic shock, bloodstream infection, invasive fungal infection, upper respiratory infection, infectious & non-infectious pneumonia, C. difficile infection, Vancomycin-resistant & -sensitive enterococcal colonization, Vancomycin-resistant & -sensitive enterococcal infections, febrile neutropenia, typhlitis, lower tract respiratory viral infections, infection-related mortality, and admission to the ICU.
Admission frequency
This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).
Compliance
This secondary objective of the trial will evaluate the degree of compliance to each diet from the time of initiation of the diet intervention until either the Absolute Neutrophil Count (ANC) is equal to or less than 500/mm3, the subject is discharged from the hospital, the subject is transferred from the unit, or after 30 days of ANC less than 500/mm3.
Patient-Generated Subjective Global Assessment (PG-SGA)
This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.
Incidence of mucositis
This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.
Symptom incidence
This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.
Quality of life (QoL)
This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.
Overall survival (OS)
This secondary objective of the trial is to evaluate OS from 1 year following randomization
Progression free survival (PFS)
This secondary objective of the trial is to evaluate PFS from 1 year following randomization
Incidence of graft vs.host disease (GVHD)
This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03016130
Brief Title
Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)
Official Title
A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome (UF-BMT-LDND-101)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and common sense advice listed in the FDA-endorsed food safety guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
leukemia, myelodysplastic, myeloid, lymphoblastic, diet, infection, hematopoietic, stem cell, transplant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liberalized Hospital Diet (Diet A)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neutropenic Diet (Diet B)
Arm Type
Active Comparator
Arm Description
Diet B is the hospital neutropenic diet.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B).
Primary Outcome Measure Information:
Title
Incidence of major infections
Description
The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of infections in each diet group
Description
This secondary objective of the trial is to compare the impact of diet on severe infections including: septic shock, bloodstream infection, invasive fungal infection, upper respiratory infection, infectious & non-infectious pneumonia, C. difficile infection, Vancomycin-resistant & -sensitive enterococcal colonization, Vancomycin-resistant & -sensitive enterococcal infections, febrile neutropenia, typhlitis, lower tract respiratory viral infections, infection-related mortality, and admission to the ICU.
Time Frame
1 year
Title
Admission frequency
Description
This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).
Time Frame
1 year
Title
Compliance
Description
This secondary objective of the trial will evaluate the degree of compliance to each diet from the time of initiation of the diet intervention until either the Absolute Neutrophil Count (ANC) is equal to or less than 500/mm3, the subject is discharged from the hospital, the subject is transferred from the unit, or after 30 days of ANC less than 500/mm3.
Time Frame
1 year
Title
Patient-Generated Subjective Global Assessment (PG-SGA)
Description
This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.
Time Frame
1 year
Title
Incidence of mucositis
Description
This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.
Time Frame
1 year
Title
Symptom incidence
Description
This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.
Time Frame
1 year
Title
Quality of life (QoL)
Description
This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.
Time Frame
1 year
Title
Overall survival (OS)
Description
This secondary objective of the trial is to evaluate OS from 1 year following randomization
Time Frame
1 year
Title
Progression free survival (PFS)
Description
This secondary objective of the trial is to evaluate PFS from 1 year following randomization
Time Frame
1 year
Title
Incidence of graft vs.host disease (GVHD)
Description
This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Undergoing treatment for hematologic malignancies or HSCT as outlined below:
Underlying diagnosis for non-HSCT patients:
Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or reinduction chemotherapy; OR
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
Allogeneic or autologous HSCT for any indication. For patients undergoing reduced intensity conditioning, only those regimens in which the expected neutropenia is ≥ 7 days are permitted and the patient must reside in the hospital
Expected duration of neutropenia of ≥ 7 days
Exclusion Criteria:
Use of anti infectives for treatment of active systemic infections within 7 days prior to initiation of study diet
Untreated major infection at presentation
Patients with uncontrolled invasive fungal infection (defined as those who have not completed at least 6 weeks of treatment; or who are symptomatic with two CT scans, at least 1 week apart showing uncontrolled disease at the time of initiation of study diet)
Uncontrolled HIV, Hepatitis B and C infection
Receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment
Patients unwilling to eat fresh fruit and/or vegetables
Planned management of neutropenia in the outpatient setting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeina A Al-Mansour, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)
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