Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The feasibility of collecting body composition assessments
研究概览
简要总结
The primary objective of this study is to evaluate the feasibility and acceptability of obtaining repeated measurements of lean muscle mass, physical function, and biological aging in children receiving active cancer therapy. The secondary objective is to evaluate the feasibility of using the D3-creatine dilution method (D3Cr) to measure skeletal muscle mass in children with cancer.
Assessments will be collected at diagnosis, once during active treatment, and end of treatment in coordination with routine imaging to monitor changes in study outcomes during active cancer treatment. Key sociodemographic, treatment and health-related factors will be abstracted from the medical record.
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
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •Ages 8-21 years at the time of cancer diagnosis
- •Must have a newly diagnosed malignant solid tumor or lymphoma.
- •Participant is expected to undergo cancer treatment with either chemotherapy, radiation, immunotherapy, or other biologically targeted therapy.
- •Participants will undergo routine imaging with either computed tomography (CT), or Magnetic Resonance Imaging (MRI) of the chest or abdomen, or whole-body positron emission tomography (PET) scan.
- •Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
- •English or Spanish speaking
- •Subject is willing and able to comply with study procedures.
- •Since the patient is undergoing active cancer therapy, must obtain approval from the treating physician.
排除标准
- •All subjects meeting any exclusion criteria at baseline will be excluded from study participation.
- •Prior history of cancer
- •Treatment with surgical excision alone
- •Planned palliative treatment.
- •Subject has elected to forgo chemotherapy or radiotherapy.
- •Any diagnosis of leukemia.
- •Clinical concerns that the treating clinician feels would preclude participation in the study.
- •Subject has a pacemaker or bilateral joint prosthesis that would prevent undergoing BIA assessment.
- •Unwilling to sign informed consent.
- •Speak a language other than English or Spanish.
研究组 & 干预措施
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: 30-second Sit-to-Stand (STS) (Other)
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: Bioelectrical impedance Analysis (BIA) (Other)
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: D3-Creatine Dilution (D3Cr) (Other)
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: 6-Minute Walk Test (6MWT) (Other)
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: Timed Up and Go (TUG) (Other)
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: Hand Grip Strength (GS) (Other)
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: PBTL p16 expression (Other)
Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
干预措施: CT, MR and PET Imaging (Other)
结局指标
主要结局
The feasibility of collecting body composition assessments
时间窗: up to 12 months
The feasibility of collecting body composition assessments will be measured as the % of participants completing all 3 assessments for each modality: D3-Creatine dilution method (D3Cr), Bioelectrical impedance Analysis (BIA), medical imaging (computerized tomography (CT), or magnetic resonance imaging (MRI), or positron emission tomography (PET).
The feasibility of collecting individual physical function assessments
时间窗: up to 12 months
The feasibility of collecting individual physical function assessments will be measured as the % of participants completing all 3 assessments for each modality namely the 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), 30-second Sit-to-Stand (STS), Hand Grip Strength (GS)) at multiple time points during cancer therapy.
次要结局
- Feasibility of collecting repeated measurements of biological aging (p16 expression)(up to 12 months)
- The acceptability of the study(up to 12 months)