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

Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03016130
• Other study ID #: IRB201700581
• Secondary ID: UF-BMT-LDND-101O
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 18, 2017
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 217
• Est. completion date: May 2024
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
United States	UF Health Cancer Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

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