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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Measured Resting Energy Expenditure to Weight-Based Equations for Parenteral Nutrition Prescribing in Oncology Patients: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07776704
- Acronym / sponsor ID
- 24-1022
- Conditions
- Malnutitrion, Cancer
- Keywords
- Parenteral Nutrition, Indirect Calorimetry, Oncology, Resting Energy Expenditure, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-Based Parenteral Nutrition Dosing | Active comparator | Dietary Supplement: Weight-Based Parenteral Nutrition DosingParenteral nutrition dosed using standard weight-based equations |
| Indirect Calorimetry-Guided Parenteral Nutrition Dosing | Experimental | Device: Indirect CalorimeterParenteral nutrition dosed based on measured resting energy expenditure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years
- Diagnosis of cancer
- Requirement for PN ≥1 week
- Ability to provide informed consent
- English-speaking
Key exclusion criteria (5 listed)
- Hospice enrollment
- Mechanical ventilation
- Chest tube or drain
- Continuous renal replacement therapy
- Supplemental oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimeterQ-NRG + metabolic monitor | Device | Indirect Calorimetry-Guided Parenteral Nutrition Dosing |
| Weight-Based Parenteral Nutrition DosingParenteral nutrition dosed using standard weight-based equations. | Dietary supplement | Weight-Based Parenteral Nutrition Dosing |
Primary outcome
Percentage of Participants in the Indirect Calorimetry Arm Completing at Least 50% of Scheduled Indirect Calorimetry Measurements
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.
Participant Acceptability of Indirect Calorimetry Measured by a 5-Point Likert Questionnaire
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.
1 secondary outcome
Percentage Change in Prescribed Parenteral Nutrition Energy Dose Following Indirect Calorimetry Measurement
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- BackgroundKopczynska M, et al. Nutrients. 2022.
- BackgroundWorthington P, et al. JPEN J Parenter Enteral Nutr. 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants in the Indirect Calorimetry Arm Completing at Least 50% of Scheduled Indirect Calorimetry Measurements (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07776704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.