Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in Serum Vitamin D Level (Group A)
研究概览
简要总结
Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue.
In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.
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
- 10 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •GROUP A: Patients with newly diagnosed ALL
- •Are greater than or equal to 10 years of age and less than or equal to 21 years of age at diagnosis of ALL
- •Have a new diagnosis of untreated ALL classified as "high risk" per NCI criteria (due to being greater than 10 years of age)
- •Are beginning treatment with a Children's Cancer Group/Children's Oncology Group "high risk" protocol with a 4-drug induction including steroids
- •Are not pregnant
- •GROUP B: Early survivors of ALL
- •Were treated for ALL and remain in first CR1 (complete remission)
- •Were equal to or greater than 10 years of age and less than or equal to 21 years of age at diagnosis of ALL
- •Have completed treatment on or as per a Children's Cancer Group/Children's Oncology Group "high risk" protocol between 12 and 48 months prior to enrollment in this study (consisting of a plan for a 4-drug induction including steroids in Induction, Delayed Intensification, and steroid pulses in Maintenance. Steroids are allowed to have been discontinued due to toxicity).
- •Are not pregnant
- •GROUP C: Siblings of Group A
- •Are either a full-sibling or a half-sibling of a patient in Group A
- •Are living at the same residence as the sibling/half-sibling from Group A
- •Are greater than or equal to 10 years of age and less than or equal to 21 years of age at the time of study entry, and within 3 years of the age diagnosis of ALL in the sibling/half-sibling from Group A
- •Are on the same Vitamin D supplementation regimen (if any) as the sibling from Group A at the time of his or her diagnosis
- •Exclusion Criteria (All Groups):
- •Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal bone development
- •Are undergoing treatment with other medicines that affect bones including chronic use of of steroids, bisphosphonate therapy, or Vitamin D at average dose greater than 400 international units (IU)/day
- •Have an underlying diseases altering body structure (i.e. missing a limb, severe dysmorphism) or severely affecting mobility (i.e. total or hemiparesis)
- •Have a history of chemotherapy or radiation for other cancers
- •Cannot complete the radiology exams/radiology exams uninterpretable (i.e. people with a hip replacement or prosthesis)
排除标准
- 未提供
结局指标
主要结局
Change in Serum Vitamin D Level (Group A)
时间窗: +6 months
Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)
次要结局
- Bone Mineral Density by QCT in Survivors at Study End (Group B)(+6 months)
- Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)(+6 months)
- Change in Vitamin D Level (Group B)(+6 months)
- Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings(1 timepoint)
研究者
Etan Orgel
Clinical Fellow
Children's Hospital Los Angeles