MalnutitrionNCT07776704
Indirect Calorimetry-Guided Parenteral Nutrition Prescribing in Oncology Patients
A study testing Indirect Calorimeter and Weight-Based Parenteral Nutrition Dosing in people with Malnutitrion and Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutitrion, Cancer
- What is being tested?
- Indirect Calorimeter and Weight-Based Parenteral Nutrition Dosing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Diagnosis of cancer
- Requirement for PN ≥1 week
- Ability to provide informed consent
- English-speaking
Who cannot join
- Hospice enrollment
- Mechanical ventilation
- Chest tube or drain
- Continuous renal replacement therapy
- Supplemental oxygen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Dylan Sherry, MD, 215-728-3544, Dylan.Sherry@fccc.edu
Dylan Sherry, MD
About this study
Official title: Comparing Measured Resting Energy Expenditure to Weight-Based Equations for Parenteral Nutrition Prescribing in Oncology Patients: A Randomized 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.
Read the 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.
- Conditions
- Malnutitrion, Cancer
- Being tested
- Indirect Calorimeter, Weight-Based Parenteral Nutrition Dosing
- Keywords
- Parenteral Nutrition, Indirect Calorimetry, Oncology, Resting Energy Expenditure, Quality of Life
- Medical subject headings
- Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimeterDevice
Q-NRG + metabolic monitor
Weight-Based Parenteral Nutrition DosingDietary supplement
Parenteral nutrition dosed using standard weight-based equations.
| Study group | Role | What they receive |
|---|---|---|
| Weight-Based Parenteral Nutrition Dosing | Active comparator | Parenteral nutrition dosed using standard weight-based equations Receives: Dietary Supplement: Weight-Based Parenteral Nutrition Dosing |
| Indirect Calorimetry-Guided Parenteral Nutrition Dosing | Experimental | Parenteral nutrition dosed based on measured resting energy expenditure Receives: Device: Indirect Calorimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start21 Aug 2025
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutitrionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dylan Sherry, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776704
- Sponsor's protocol ID
- 24-1022
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Kopczynska M, et al. Nutrients. 2022.
Worthington P, et al. JPEN J Parenter Enteral Nutr. 2017.