Indirect Calorimetry-Guided Parenteral Nutrition Prescribing in Oncology Patients

NCT07776704 | Recruiting FDA Device

• 1 other identifier: 24-1022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutitrion; Cancer

Keywords

Parenteral Nutrition; Indirect Calorimetry; Oncology; Resting Energy Expenditure; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 4, and Week 8

Secondary Outcomes (1)

• Percentage Change in Prescribed Parenteral Nutrition Energy Dose Following Indirect Calorimetry Measurement

  Up to 3 months

Other Outcomes (5)

• Incidence of Parenteral Nutrition Access-Related Infections

  Up to 3 months

• Incidence of Parenteral Nutrition-Related Edema or Ascites

  Up to 3 months

• Incidence of Parenteral Nutrition-Related Metabolic Abnormalities

  Up to 3 months

Study Arms (2)

Weight-Based Parenteral Nutrition Dosing

ACTIVE COMPARATOR

Parenteral nutrition dosed using standard weight-based equations

Dietary Supplement: Weight-Based Parenteral Nutrition Dosing

Indirect Calorimetry-Guided Parenteral Nutrition Dosing

EXPERIMENTAL

Parenteral nutrition dosed based on measured resting energy expenditure

Device: Indirect Calorimeter

Interventions

Indirect Calorimeter DEVICE

Q-NRG + metabolic monitor

Indirect Calorimetry-Guided Parenteral Nutrition Dosing

Weight-Based Parenteral Nutrition Dosing DIETARY_SUPPLEMENT

Parenteral nutrition dosed using standard weight-based equations.

Weight-Based Parenteral Nutrition Dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years
• Diagnosis of cancer
• Requirement for PN ≥1 week
• Ability to provide informed consent
• English-speaking

You may not qualify if:

• Hospice enrollment
• Mechanical ventilation
• Chest tube or drain
• Continuous renal replacement therapy
• Supplemental oxygen

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Related Publications (2)

• Kopczynska M, et al. Nutrients. 2022.

  BACKGROUND

• Worthington P, et al. JPEN J Parenter Enteral Nutr. 2017.

  BACKGROUND

MeSH Terms

Conditions

Neoplasms; Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 20, 2026
• Study Start: August 21, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)