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

University of Florida

Status and phase: Terminated; Phase 3

Conditions: Leukemia; Myelodysplastic Syndromes

Treatments: Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03016130

UF-HEM-007 (Other Identifier)

OCR15632 (Other Identifier)

UF-BMT-LDND-101 (Other Identifier)

IRB201700581

Details and patient eligibility

About

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.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

Liberalized Hospital Diet (Diet A)

Active Comparator group

Description:

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.

Treatment:

Other: Diet

Neutropenic Diet (Diet B)

Active Comparator group

Description:

Diet B is the hospital neutropenic diet.

Treatment:

Other: Diet