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临床试验/NCT03621124
NCT03621124终止不适用

Maladaptive Adipose Tissue Activity in Cancer

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.

研究概览

简要总结

The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer.

详细描述

The purpose of this research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer. Many patients affected by cancer lose weight, despite normal or increased nutrition. It may progress to the condition called "cancer-associated cachexia." Cancer associated cachexia is defined by an ongoing loss of skeletal muscle mass with or without the loss of fat mass, and may negatively affect quality of life and the ability to undergo cancer treatments. Metabolism is the breakdown of food by the body into the energy that your body needs.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 40 years of age
  • Have active cancer diagnosis.
  • Have had a PET/CT scan within the past 12 months at time of enrollment.
  • Ability to understand and the willingness to sign a written informed consent document

排除标准

  • Current use of beta-blockers
  • Women who are pregnant or unsure of their pregnancy status
  • Women who are breastfeeding
  • Suffers from severe claustrophobia
  • Diagnosed with a serious psychiatric condition which could impede the judgement of the investigators, and/or the successful conduct of the recording.
  • In remission stage for cancer diagnosis

研究组 & 干预措施

Brown Adipose Tissue Positive patients

Patients with known malignancy and incidental finding of positron emission tomography/ computerized tomography (PET/CT) scans positive for brown adipose tissue (BAT). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.

干预措施: Resting Energy Expenditure (Procedure)

Brown Adipose Tissue Positive patients

Patients with known malignancy and incidental finding of positron emission tomography/ computerized tomography (PET/CT) scans positive for brown adipose tissue (BAT). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.

干预措施: Thermal Comfort Questionnaire (Other)

Brown Adipose Tissue Negative Patients

Patients with known malignancy and no evidence of brown adipose tissue BAT activity positron emission tomography/ computerized tomography (PET/CT) scans to be matched to group 1 for primary tumor and stage, sex, age (±5 years), BMI (±3 Kg/m2). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.

干预措施: Resting Energy Expenditure (Procedure)

Brown Adipose Tissue Negative Patients

Patients with known malignancy and no evidence of brown adipose tissue BAT activity positron emission tomography/ computerized tomography (PET/CT) scans to be matched to group 1 for primary tumor and stage, sex, age (±5 years), BMI (±3 Kg/m2). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room.

干预措施: Thermal Comfort Questionnaire (Other)

结局指标

主要结局

Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.

时间窗: 27 Months

Characterization of the energy metabolism profiles of cancer patients with and without evidence of BAT activation will be assessed utilizing one sided t-test.

次要结局

  • Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.(27 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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