Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/16/2019 |
| Start Date: | August 18, 2017 |
| End Date: | September 1, 2025 |
| Contact: | Alisha J. Daniels, MD, MHA |
| Email: | alisha.daniels@ufl.edu |
| Phone: | (352) 294-8568 |
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)
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.
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.
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 systemic antibacterial antibiotics 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
- Use of neutropenic diet within 72 hours prior to consent
- 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
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