Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of nutrition and exercise intervention
研究概览
简要总结
This clinical trial aims to assess the effect of nutrition and exercise on muscle and adiposity in adults with Philadelphia Chromosome (Ph) Negative B-ALL undergoing inpatient induction therapy.
Participants will take part in 2 different interventions:
- Nutrition Intervention
- Physical Exercise Intervention
All subjects will be provided with a wearable electronic activity monitor (FitBit®) to assist in recording activity levels in minutes of activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New Diagnosis of Philadelphia Chromosome Negative B-ALL
- •Receiving intensive pediatric-inspired induction chemotherapy
排除标准
- •BMI ≤18.5 kg/m2 at time of diagnosis
- •Unable to comply with both the recommended diet and exercise regimen as deemed by the research or treatment team
研究组 & 干预措施
Nutrition and Exercise interventions
Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL.
干预措施: Nutrition Intervention (Behavioral)
Nutrition and Exercise interventions
Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL.
干预措施: Exercise intervention (Behavioral)
结局指标
主要结局
Feasibility of nutrition and exercise intervention
时间窗: End of study recruitment (approximately 1 year)
Percentage of eligible patients that consent to trial.
次要结局
- Adherence to dietary intervention(22 days)
- Adherence to exercise intervention(22 days)
- Usability of interventions(22 days)
- Body composition changes - Visceral Adiposity(22 days)
- Body composition changes - Sarcopenia (SMI)(22 days)
- Impact on minimal residual disease (MRD)(22 days)
- Impact on Treatment toxicities(22 days)
- Changes to the Host Metabolome(22 days)