Resting Energy Expenditure in Palliative Cancer Patients (REPAT)

Resting Energy Expenditure in Palliative Cancer Patients (REPAT) - an Explorative Study in Patients With Incurable Cancer

The study purpose is to measure REE by indirect calorimetry and to determine limits of agreement with confidence intervals between measured REE and predictive equations for determination of energy requirements in patients with incurable cancer. Clinical factors associated with hyper- and hypometabolism will be elucidated. Data will be obtained from patient journals in combination with measurements of REE and registration of survival. Data will be collected at one timepoint and survival will be monitored prospectively.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Cachexia

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Trude R Balstad, PhD; Phone Number: +4792282665; Email: trude.r.balstad@ntnu.no
• Study Contact Backup: Name: Marianne Erichsen, M.Sc.; Phone Number: +4740053267; Email: marianne.erichsen@uit.no

Study Locations

• Norway
  • Trondheim, Norway, 7021
    • Recruiting
    • Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital
    • Contact: Trude R Balstad, PhD; Phone Number: +4792282665; Email: trude.r.balstad@ntnu.no
    • Contact: Tora Solheim, PhD; Phone Number: +4792049507; Email: tora.s.solheim@ntnu.no
    • Sub-Investigator: Lene Thoresen, PhD
    • Sub-Investigator: Morten Thronæs, PhD
    • Sub-Investigator: Erik Løhre, PhD
    • Sub-Investigator: Gunnhild Jakobsen, PhD
    • Sub-Investigator: Patrik Hansson, PhD
    • Sub-Investigator: Ingvild Paur, PhD
    • Sub-Investigator: Inger Ottestad, PhD
    • Sub-Investigator: Turid Follestad, PhD
    • Sub-Investigator: Vilde Ressem Strøm, B.Sc
    • Sub-Investigator: Marie Sjøvoll Christensen Strøm, B.Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population is patients diagnosed with an incurable malignant disease and hospitalized at the cancer clinic, St. Olavs Hospital in the period from september 2023 to june 2026. They have to be 18 years or older and able to provide written informed consent and comply with all study procedures.

Description

Inclusion Criteria:

• A verified diagnosis of an incurable malignant disease
• Hospitalized at the Cancer clinic, St. Olavs Hospital
• ≥ 18 years of age
• Able to provide written informed consent
• Able to comply with all study procedures

Exclusion Criteria:

• Cognitive impairment
• In need of supplementary oxygen
• Receiving invasive or noninvasive ventilation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of resting energy expenditure (REE) in patients with incurable cancer measured with the COSMED Q-NRG+ Indirect Calorimeter with a Canopy Hood.	Investigate the agreement between the most used energy expenditure prediction equation (Harris-Benedict calculation for resting energy expenditure based on weight, height and gender) and measured REE (kilocalories/day) by indirect calorimetry in patients with incurable cancer.	Throughout study completion, approximately 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical factors associated with hyper- and hypometabolism	Explore the association between patients identified as hyper-or hypometabolic (REE > 10% or < 10% of the predicted BMR (in kilocalories per day)) and a set of explanatory variables such as cancer diagnosis (type), weight loss last six months ((current/past weight)*100), symptom score (Edmonton Symptom Assessment System (ESAS)), degree of inflammation (CRP in mg/L), and survival (days after REE measurement).	Throughout study completion, approximately 3 years.

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; UiT The Arctic University of Norway

Publications and helpful links

Helpful Links

• Current Research Information System in Norway

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Thinness; Cachexia
• Other Study ID Numbers: 622545

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No