Title: Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS
Principal Investigator: Zeina A. Al-Mansour, MD, University of Florida
Description: Investigators are conducting a phase 3 non-inferiority trial to compare a neutropenic diet with a liberalized hospital diet in patients with myelodysplastic syndromes (MDS) or acute leukemia who have prolonged neutropenia.
Both cohorts and diets will adhere to food safety guidelines endorsed by the US Food and Drug Administration.
Diet A will consist of fresh fruits and/or vegetables in a liberalized hospital diet. Patients will be encouraged to eat at least 1 daily serving of fresh fruits and/or vegetables. Diet B consists of the hospital neutropenic diet.
The trial’s primary objective is to compare the incidence of major infections with Diet A and Diet B in patients treated with hematopoietic stem cell transplant (HSCT) or induction chemotherapy who have prolonged neutropenia (lasting 7 days or fewer).
Secondary endpoints include severe infections (such as septic shock and invasive fungal infection), ICU admission, compliance, nutritional status, mucositis, symptoms, quality of life, progression-free and overall survival, and graft-vs-host disease.
To be eligible for the study, patients should be 18 years or older, have acute lymphoblastic leukemia, acute myeloid leukemia, or MDS. They must be undergoing allogeneic/autologous HSCT or receiving induction/reinduction chemotherapy. For a complete list of eligibility criteria, please refer to the reference.
This study is sponsored by the University of Florida.
Clinicaltrials.gov. Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101). NCT03016130. Accessed October 20, 2021.