Validation of Eight-Electrode Multifrequency Bioelectrical Impedance Analysis to Estimate Body Composition in a Head and Neck Cancer Population Undergoing Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lean and Fat Body Mass Composition from SECA mBCA BIA Scale Compared with Computed Tomography (CT) in Participants with Head and Neck Cancer Undergoing Radiation Therapy (RT)
研究概览
简要总结
Bioelectrical impedance analysis measures body mass (the amount of muscle and fat in the body) and the level of hydration to help researchers identify patients who are losing muscle mass during radiation therapy. This information may help researchers make decisions about nutritional supplementation and the placement of feeding tubes in patients receiving radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To validate body composition estimates derived from the seca (SECA) medical body composition analyzer (mBCA) bioelectrical impedance analysis (BIA) scale by comparing with computed tomography (CT) measured lean and fat body mass.
SECONDARY OBJECTIVES:
I. Evaluate sensitivity of mBCA to detect changes in body composition during treatment.
II. Identify whether BIA-estimated loss of lean body mass (LBM) during treatment predicts development of sarcopenia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented head and neck cancer (clinical stage I-IVB; Tx,1-4, N0-3).
- •Patients dispositioned to receive radiation therapy (dose >= 60 gray [Gy]).
- •Patients may receive radiation as either primary therapy or post-operatively.
- •Patient received staging positron emission tomography/computed tomography (PET/CT) scan during 60-day period prior to initiating therapy.
- •Negative pregnancy test for women of child bearing potential.
排除标准
- •Previous radiation treatment for head and neck mucosal primary cancers (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity).
- •Patients with pacemaker, implanted cardiac defibrillator, or vagal nerve stimulator.
- •Pregnant or breast-feeding females.
- •Patients weighing over 660 lbs (300 kg).
- •Patients with other medical conditions known to cause sarcopenia, including New York Heart Association (NYHA) class III-IV heart failure, oxygen-dependent pulmonary disease, advanced human immunodeficiency virus infection, cirrhosis, end stage renal disease, or inherited/congenital disorders of metabolism.
- •Patients receiving palliative irradiation.
研究组 & 干预措施
Supportive Care (bioelectrical impedance analysis, RT)
Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.
干预措施: Bioelectric Impedance Analysis (Procedure)
Supportive Care (bioelectrical impedance analysis, RT)
Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.
干预措施: Computed Tomography (Procedure)
Supportive Care (bioelectrical impedance analysis, RT)
Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.
干预措施: Positron Emission Tomography (Procedure)
Supportive Care (bioelectrical impedance analysis, RT)
Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (bioelectrical impedance analysis, RT)
Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.
干预措施: Questionnaire Administration (Other)
Supportive Care (bioelectrical impedance analysis, RT)
Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Lean and Fat Body Mass Composition from SECA mBCA BIA Scale Compared with Computed Tomography (CT) in Participants with Head and Neck Cancer Undergoing Radiation Therapy (RT)
时间窗: 7 weeks
Validation of BIA measures of body composition made by comparison with CT-based estimates of body composition. Linear regression analysis used to determine the relative agreement between lean body mass and fat body mass predicted from impedance measurement and CT imaging.
次要结局
- BIA-derived body composition calculations(Up to 2 years)