Comparing Measured Resting Energy Expenditure to Weight-Based Equations for Parenteral Nutrition Prescribing in Oncology Patients: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Participants in the Indirect Calorimetry Arm Completing at Least 50% of Scheduled Indirect Calorimetry Measurements
研究概览
简要总结
This study compares two methods of prescribing parenteral nutrition (PN) in adults with cancer who are unable to meet nutritional needs by oral or enteral intake.
详细描述
This is a single-center, randomized, open-label pilot study enrolling 50 adult oncology patients requiring PN (parenteral nutrition). Participants are randomized to weight-based dosing or indirect calorimetry-guided dosing. Outcomes include feasibility, acceptability, changes in PN prescription, adverse events, quality of life, and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adults aged ≥18 years
- •Diagnosis of cancer
- •Requirement for PN ≥1 week
- •Ability to provide informed consent
- •English-speaking
排除标准
- •Hospice enrollment
- •Mechanical ventilation
- •Chest tube or drain
- •Continuous renal replacement therapy
- •Supplemental oxygen
研究组 & 干预措施
Weight-Based Parenteral Nutrition Dosing
Parenteral nutrition dosed using standard weight-based equations
干预措施: Weight-Based Parenteral Nutrition Dosing (Dietary Supplement)
Indirect Calorimetry-Guided Parenteral Nutrition Dosing
Parenteral nutrition dosed based on measured resting energy expenditure
干预措施: Indirect Calorimeter (Device)
结局指标
主要结局
Percentage of Participants in the Indirect Calorimetry Arm Completing at Least 50% of Scheduled Indirect Calorimetry Measurements
时间窗: Up to 8 weeks
Feasibility will be assessed as the proportion of participants randomized to the indirect calorimetry intervention arm who complete at least 50% of scheduled indirect calorimetry measurements during the 8-week intervention period. Scheduled measurements will occur weekly while inpatient and every 4 weeks while outpatient per protocol.
Participant Acceptability of Indirect Calorimetry Measured by a 5-Point Likert Questionnaire
时间窗: Baseline, Week 4, and Week 8
Acceptability will be assessed using a 7-item participant questionnaire developed for this study evaluating comfort, understanding, satisfaction, and willingness to undergo indirect calorimetry again. Five items are scored on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate greater acceptability of indirect calorimetry. Acceptability will be summarized using mean questionnaire scores and the percentage of participants reporting agreement or strong agreement with overall acceptability.
次要结局
- Percentage Change in Prescribed Parenteral Nutrition Energy Dose Following Indirect Calorimetry Measurement(Up to 3 months)
研究者
Dylan Sherry
Principal Investigator
Fox Chase Cancer Center