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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016130
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Other: Diet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 18, 2017
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Incidence of major infections [ Time Frame: 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 :
  1. Incidence of infections in each diet group [ Time Frame: 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.

  2. Admission frequency [ Time Frame: 1 year ]
    This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).

  3. Compliance [ Time Frame: 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.

  4. Patient-Generated Subjective Global Assessment (PG-SGA) [ Time Frame: 1 year ]
    This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.

  5. Incidence of mucositis [ Time Frame: 1 year ]
    This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.

  6. Symptom incidence [ Time Frame: 1 year ]
    This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.

  7. Quality of life (QoL) [ Time Frame: 1 year ]
    This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.

  8. Overall survival (OS) [ Time Frame: 1 year ]
    This secondary objective of the trial is to evaluate OS from 1 year following randomization

  9. Progression free survival (PFS) [ Time Frame: 1 year ]
    This secondary objective of the trial is to evaluate PFS from 1 year following randomization

  10. Incidence of graft vs.host disease (GVHD) [ Time Frame: 1 year ]
    This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016130


Contacts
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Contact: Kim Pena del Aguila (352) 273-5739 PMO@cancer.ufl.edu

Locations
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United States, Florida
UF Health Cancer Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Nadine Hill       nadinehill@ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Zeina A Al-Mansour, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03016130    
Other Study ID Numbers: IRB201700581
UF-BMT-LDND-101 ( Other Identifier: University of Florida )
OCR15632 ( Other Identifier: UF OnCore )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
leukemia
myelodysplastic
myeloid
lymphoblastic
diet
infection
hematopoietic
stem cell
transplant
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions