Indirect Calorimetry-Guided Parenteral Nutrition Prescribing in Oncology Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Indirect Calorimeter

    Device

    Q-NRG + metabolic monitor

  • Weight-Based Parenteral Nutrition Dosing

    Dietary supplement

    Parenteral nutrition dosed using standard weight-based equations.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Weight-Based Parenteral Nutrition DosingActive comparator 1 intervention
Group B: Indirect Calorimetry-Guided Parenteral Nutrition DosingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 8 weeks
2

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

Secondary outcomes

1

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

Other outcomes

1

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.

Time frame
Up to 3 months
2

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.

Time frame
Up to 3 months
3

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.

Time frame
Up to 3 months
4

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.

Time frame
Up to 90 Days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.