LCI-PED-NOS-EXER-001: Just Move. A Randomized Controlled Trial Investigating Exercise in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
研究概览
简要总结
The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.
详细描述
This is a randomized, controlled trial to investigate if a structured exercise regimen will have benefit relative to the control arm by increasing and /or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test and BOT-2 Brief or PDMS-2.
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
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 2-25 at time of consent
- •Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy for at least 3 full cycles
- •Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language
- •As determined and documented by the enrolling investigator, ability of the subject to understand and comply with study procedures for the entire length of the study
- •Subject has newly diagnosed cancer per Investigator and is planning to undergo chemotherapy, immunotherapy, or other systemically delivered for treatment of malignancy. Subjects are allowed to be enrolled up to 21 days after initiating cancer treatment.
- •Receiving oncologic care at Levine Children's Cancer and Blood Disorders Clinic.
- •Subject is anticipated to receive at least 3 full cycles of chemotherapy or other systemic cancer treatment.
- •Not participating in another clinical trial that precludes participating in additional nondrug clinical trials.
排除标准
- •Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program
- •Any other uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements or would be considered unsafe for the child to participate as determined by the Investigator.
- •Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion
- •Primary CNS Tumor
- •Osteosarcoma
研究组 & 干预措施
EXER
"Just Move" exercises
干预措施: "Just Move" Exercise (Other)
SOC EXER
Standard of Care Exercise
干预措施: Standard of Care Exercise (Other)
结局指标
主要结局
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
时间窗: 18 month period
Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test
次要结局
- Adverse Events Related to Exercise Program(up to 18 months)
- Adverse Event Rate(up to 18 months)
- Quality of Life measured by the PedsQL Cancer Module(up to 18 months)
- Subject adherence to exercise regimen(up to 18 months)