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

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT03016130

Collaborator

(none)

470

Enrollment

Location

Arms

96.5

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes	Other: Diet	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

470 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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)

Actual Study Start Date :

Aug 18, 2017

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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).

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

Outcome Measures

Primary Outcome Measures

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

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.
Admission frequency [1 year]
This secondary objective of the trial will examine the admission frequency to the intensive care unit (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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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