Clinical trial NCT03016130: Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Leukemia
Myelodysplastic Syndromes
Keywords: leukemia
myelodysplastic
myeloid
lymphoblastic
diet
infection
hematopoietic
stem cell
transplant
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Incidence of major infections
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of infections in each diet group
timeFrame: 1 year
measure: Admission frequency
timeFrame: 1 year
measure: Compliance
timeFrame: 1 year
measure: Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: 1 year
measure: Incidence of mucositis
timeFrame: 1 year
measure: Symptom incidence
timeFrame: 1 year
measure: Quality of life (QoL)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
measure: Progression free survival (PFS)
timeFrame: 1 year
measure: Incidence of graft vs.host disease (GVHD)
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Center
state: Florida
Study officials:
affiliation: University of Florida
name: Paul Crispen, MD
role: PRINCIPAL_INVESTIGATOR
References: