NCT Number: NCT07776704
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19111, United States
Location status: Recruiting
Dylan Sherry, MD
CONTACT
Dylan Sherry, MD
PRINCIPAL_INVESTIGATOR
Jaylin Kellogg, MS, RD, LDN, CNSC
SUB_INVESTIGATOR
Jessica Bauman, MD
SUB_INVESTIGATOR
Kara Stromberg, MS, RD, LDN, CDE
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Q-NRG + metabolic monitor
Parenteral nutrition dosed using standard weight-based equations.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
Metabolic abnormalities related to PN administration, including hyperglycemia, hypertriglyceridemia, liver function abnormalities, or transaminitis, will be assessed through laboratory review and clinical documentation.
Time frame: Up to 90 Days
Hospital admissions and reasons for admission will be collected through electronic medical record review and outside hospital records when available.
Time frame: 180 days
Overall survival will be assessed by chart review at 180 days following enrollment.
Fox Chase Cancer Center
Other
Comparing Measured Resting Energy Expenditure to Weight-Based Equations for Parenteral Nutrition Prescribing in Oncology Patients: A Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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