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

Phase 3

Terminated

• Conditions: Leukemia; Myelodysplastic Syndromes
• Interventions: Other: Diet

• Registration Number: NCT03016130
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Study Start: 2017-08-18
• Primary Completion: 2023-05-29
• Study Completion: 2024-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 217

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberalized Hospital Diet (Diet A)	Diet	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.
Neutropenic Diet (Diet B)	Diet	Diet B is the hospital neutropenic diet.

Primary Outcome Measures

Name	Time	Method
Incidence of major infections	1 year	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

Name	Time	Method
Patient-Generated Subjective Global Assessment (PG-SGA)	1 year	This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.
Incidence of mucositis	1 year	This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.
Symptom incidence	1 year	This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.
Quality of life (QoL)	1 year	This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.
Admission frequency	1 year	This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).
Incidence of infections in each diet group	1 year	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.
Compliance	1 year	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.
Overall survival (OS)	1 year	This secondary objective of the trial is to evaluate OS from 1 year following randomization
Progression free survival (PFS)	1 year	This secondary objective of the trial is to evaluate PFS from 1 year following randomization
Incidence of graft vs.host disease (GVHD)	1 year	This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.

Trial Locations

Locations (1)

UF Health Cancer Center; 🇺🇸 Gainesville, Florida, United States