About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years
Diagnosis of cancer
Requirement for PN ≥1 week
Ability to provide informed consent
Disqualifiers
Hospice enrollment
Mechanical ventilation
Chest tube or drain
Continuous renal replacement therapy
Trial design
Parallel
Treatments tested in this trial
Indirect Calorimeter
DeviceQ-NRG + metabolic monitor
Weight-Based Parenteral Nutrition Dosing
Dietary supplementParenteral nutrition dosed using standard weight-based equations.
Treatment groups
Trial outcomes
Primary outcomes
Percentage 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.
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.
Secondary outcomes
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.
Other outcomes
Incidence of Parenteral Nutrition Access-Related Infections
PN access-related infections will be identified through chart review using clinical documentation, ICD-10 diagnosis codes, antibiotic treatment, and timing of infection relative to PN administration.
Incidence of Parenteral Nutrition-Related Edema or Ascites
PN-related edema or ascites will be assessed through chart review, imaging findings, physical examination findings, need for paracentesis/thoracentesis, changes in diuretic therapy, and CTCAE grade 2 or higher fluid-related adverse events.
Incidence of Parenteral Nutrition-Related Metabolic Abnormalities
Metabolic abnormalities related to PN administration, including hyperglycemia, hypertriglyceridemia, liver function abnormalities, or transaminitis, will be assessed through laboratory review and clinical documentation.
Number of Hospital Admissions During Parenteral Nutrition Therapy
Hospital admissions and reasons for admission will be collected through electronic medical record review and outside hospital records when available.
Sponsors and contacts
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