Assessing Whole-body Metabolism in Gynecologic Cancers in Response to a Single Chemotherapy Cycle and/ or Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Fasting Whole Body Carbon Dioxide Production - Baseline
研究概览
简要总结
It is well established that cancer cells have fundamentally altered metabolism, which contributes to tumorigenicity and malignancy. For years, research findings supported that the universal property of all cancer cells was to increase glycolytic flux for anaerobic glycolysis (i.e., Warburg effect), which was accepted as the dominant pathway for energy metabolism. Fortunately, by understanding these changes in cellular metabolism multiple new approaches to cancer therapy, focused on reprogramming the energy metabolism of the cell. Recently, further investigation in the field found that cancer cells exhibit multiple alterations in metabolic pathways, not only glycolysis.
Alterations in lipid metabolism in cancer cells have recently been recognized as potential targets for therapeutic interventions due to its role in cellular proliferation, energy storage, and the generation of signaling molecules. Numerous cancer types can rely on lipids as an energy source, increasing fatty acid synthesis and degradation to promote proliferation and metastasis. Several therapeutic agents utilized in gynecologic malignancies impact lipid metabolism.
The objective of the proposed study will be to determine the impact of cancer directed therapy on the lipid metabolism of non-malignant tissues. No study to date has assessed whole-body lipid metabolism in patients undergoing chemotherapy (i.e. cytotoxic chemotherapy and/or immunotherapy). These novel findings will provide crucial knowledge about the dysregulation of whole-body metabolism in patients receiving chemotherapy for treatment of gynecologic cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Biopsy confirmed gynecologic cancer.
- •Scheduled to or currently undergoing infusion therapy.
- •Receiving cytotoxic chemotherapy or immunotherapy.
排除标准
- •Inability to provide voluntary informed consent.
- •Received inpatient medical intervention for adverse effects of chemotherapy.
- •Circumstances and/or medical condition that would limit compliance with study requirements and protocol, as determined by the principal investigators.
研究组 & 干预措施
Patients with biopsy proven gynecologic cancer
Patients with biopsy proven gynecologic cancer undergoing active treatment
结局指标
主要结局
Fasting Whole Body Carbon Dioxide Production - Baseline
时间窗: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - Baseline
时间窗: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - Baseline
时间窗: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - Baseline
时间窗: Fasting, measured at the start of the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Fasting Whole Body Carbon Dioxide Production - 30 Minutes Post
时间窗: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - 30 Minutes Post
时间窗: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - 30 Minutes Post
时间窗: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - 30 Minutes Post
时间窗: Fasting, measured 30 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Fasting Whole Body Carbon Dioxide Production - 90 Minutes Post
时间窗: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - 90 Minutes Post
时间窗: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - 90 Minutes Post
时间窗: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - 90 Minutes Post
时间窗: Fasting, measured 90 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
Fasting Whole Body Carbon Dioxide Production - 150 Minutes Post
时间窗: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body carbon dioxide production (VCO2), which is assessed using indirect calorimetry and measured in ml/min.
Fasting Whole Body Oxygen Consumption - 150 Minutes Post
时间窗: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting whole body oxygen consumption (VO2), which is assessed using indirect calorimetry in ml/min
Fasting Resting Metabolic Rate (RMR) - 150 Minutes Post
时间窗: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting resting metabolic rate (RMR), which is assessed using indirect calorimetry and measured in kcal/day.
Fasting respiratory exchange ratio (RER) - 150 Minutes Post
时间窗: Fasting, measured 150 minutes after the start of a single cancer treatment during the study visit at one time point during active cancer treatment.
Fasting respiratory exchange ratio (RER), which is assessed using indirect calorimetry.
次要结局
- Fasting capillary blood glucose(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting capillary blood lactate(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous blood glucose(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous blood insulin(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous blood lactate(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous cholesterol (mg/dL)(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous HDL (mg/dL)(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous LDL (mg/dL)(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous VLDL (mg/dL)(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)
- Fasting venous triglycerides (mg/dL)(Fasting, measured at the start of the study visit at one time point during active cancer treatment.)