Cancer, Malnutitrion
Conditions
Keywords
Parenteral Nutrition, Indirect Calorimetry, Oncology, Resting Energy Expenditure, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIndirect Calorimeter
Q-NRG + metabolic monitor
DIETARY_SUPPLEMENTWeight-Based Parenteral Nutrition Dosing
Parenteral nutrition dosed using standard weight-based equations.
Sponsors
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥18 years * Diagnosis of cancer * Requirement for PN ≥1 week * Ability to provide informed consent * English-speaking
Exclusion criteria
* Hospice enrollment * Mechanical ventilation * Chest tube or drain * Continuous renal replacement therapy * Supplemental oxygen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in the Indirect Calorimetry Arm Completing at Least 50% of Scheduled Indirect Calorimetry Measurements | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Prescribed Parenteral Nutrition Energy Dose Following Indirect Calorimetry Measurement | Up to 3 months | 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. |
Countries
United States
Outcome results
None listed