Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myelodysplastic Syndromes; Leukemia
• Intervention / Treatment: Other: Diet

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexandra Mueller; Phone Number: (352) 273-9785; Email: PMO@cancer.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • UF Health Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liberalized Hospital Diet (Diet A); 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.	Other: Diet; 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).
Active Comparator: Neutropenic Diet (Diet B); Diet B is the hospital neutropenic diet.	Other: Diet; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Admission frequency	This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).	1 year
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.	1 year
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.	1 year
Incidence of mucositis	This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.	1 year
Symptom incidence	This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.	1 year
Quality of life (QoL)	This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.	1 year
Overall survival (OS)	This secondary objective of the trial is to evaluate OS from 1 year following randomization	1 year
Progression free survival (PFS)	This secondary objective of the trial is to evaluate PFS from 1 year following randomization	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Zeina A Al-Mansour, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2017
• Primary Completion (Actual): May 29, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimated): January 10, 2017

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: transplant; infection; stem cell; diet; leukemia; lymphoblastic; myeloid; hematopoietic; myelodysplastic
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Leukemia; Preleukemia
• Other Study ID Numbers: IRB201700581; UF-BMT-LDND-101 (Other Identifier: University of Florida); OCR15632 (Other Identifier: UF OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No