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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Incidence of major infections
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Liberalized Hospital Diet (Diet A)
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.
干预措施: Diet (Other)
Neutropenic Diet (Diet B)
Diet B is the hospital neutropenic diet.
干预措施: Diet (Other)
结局指标
主要结局
Incidence of major infections
时间窗: 1 year
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.
次要结局
- Overall survival (OS)(1 year)
- Incidence of mucositis(1 year)
- Symptom incidence(1 year)
- Patient-Generated Subjective Global Assessment (PG-SGA)(1 year)
- Quality of life (QoL)(1 year)
- Admission frequency(1 year)
- Incidence of infections in each diet group(1 year)
- Compliance(1 year)
- Progression free survival (PFS)(1 year)
- Incidence of graft vs.host disease (GVHD)(1 year)