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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Q-NRG + metabolic monitor
Parenteral nutrition dosed using standard weight-based equations.
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGPercentage of Participants in the Indirect Calorimetry Arm Completing at Least 50% of Scheduled Indirect Calorimetry Measurements
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.
Time frame: Up to 8 weeks
Participant Acceptability of Indirect Calorimetry Measured by a 5-Point Likert Questionnaire
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.
Time frame: Baseline, Week 4, and Week 8
Percentage Change in Prescribed Parenteral Nutrition Energy Dose Following Indirect Calorimetry Measurement
The outcome will assess the percentage change in prescribed parenteral nutrition caloric dose (kcal/day) after indirect calorimetry measurement compared with the initial weight-based prescription. Changes in PN dosing attributable to indirect calorimetry-guided resting energy expenditure measurements will be recorded at each reassessment.
Time frame: Up to 3 months
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