Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fat Mass
研究概览
简要总结
This study tests the ability of a focused dietary, exercise, and activity intervention to reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to improve disease response and reduce toxicity.
详细描述
In our previous study, we have observed that: 1) nearly half ALL patients are overweight or obese at diagnosis, 2) all patients, regardless of starting weight, gain significant fat mass over the first month of therapy (on average 20-30%), and 3) obesity at the time of diagnosis is associated with a higher likelihood of poor response to chemotherapy as evidenced by persistent leukemia (minimal residual disease) after induction therapy. Together, these data show that body fat is a significant risk factor for ALL treatment failure, and that its negative effects are evident within the first month of treatment. Recent laboratory and clinical data illustrates the ability of diet restriction and physical activity to improve chemotherapy efficacy, reduce treatment-related toxicities and better overall quality of life.
Given the importance of successful induction therapy for ALL in predicting long term survival and the negative role of obesity on treatment success, this study tests a complete personalized dietary and exercise intervention for pre-adolescents, adolescents, and young adults newly diagnosed with B-precursor ALL ("pre-B ALL") that aims to reduce fat gained during induction therapy and thereby improve treatment response, toxicity rates, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 10 years of age and less than or equal to 21 years of age at time of diagnosis
- •Have a new diagnosis of untreated NCI/Rome High Risk B-precursor ALL (HR-ALL)
- •Are beginning treatment on- or as per- a Children's Cancer Group/Children's Oncology Group (CCG-COG) protocol with a 4-drug Induction including vincristine, daunorubicin (or doxorubicin), asparaginase, and at least 14 days of glucocorticoid steroids
排除标准
- •Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal body composition
- •Be underweight or "at risk for underweight" with moderate weight loss, defined as a starting Body Mass Index (BMI) <10th percentile for age and sex (for those >20 years of age, defined as an absolute BMI < 18.5)
- •Have pre-existing abnormal intestinal function (e.g. protein-wasting enteropathy, fat malabsorption)
- •Be unable to comply with the recommended diet or activity interventions (as determined by study or treatment team)
- •Have a history of prior chemotherapy or radiation for other cancers
- •Be unable to complete the necessary radiology examinations with fully interpretable data (e.g. hip replacement and metal prostheses preclude evaluation by DXA)
- •Be pregnant (to be confirmed by urine or serum pregnancy test as per institutional routine care for chemotherapy and radiology exams)
研究组 & 干预措施
Obesity Intervention
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
干预措施: Dietary Intervention (Behavioral)
Obesity Intervention
Personalized 28-day Dietary Intervention and Activity and Exercise Intervention with the goal to reduce fat gain and lean muscle loss while inducing an overall negative energy balance.
干预措施: Activity and Exercise Intervention (Behavioral)
结局指标
主要结局
Fat Mass
时间窗: Diagnosis and 28-35 days
Assessment of change in fat before and after the induction chemotherapy phase (first 28 days of chemotherapy) as measured dual-energy x-ray absorptiometry (DXA) in comparison to fat gain in a recent historical cohort. Calculated as (Day 28 Fat Mass - Diagnosis Fat Mass)/Diagnosis Fat Mass
次要结局
- Percentage of Overall Adherence to the IDEAL Intervention(28 days)
- Percentage of Successfully Completed Visits With Study Dietitian and Study Physiotherapist(28 days)
- Percentage of Participants With Minimal Residual Disease >=0.01%(28-35 days from diagnosis)
研究者
Etan Orgel
Assistant Professor of Clinical Pediatrics
Children's Hospital Los Angeles