Resting Energy Expenditure in Palliative Cancer Patients

Recruiting

• Conditions: Cancer; Cachexia

• Registration Number: NCT06206785
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-05
• Study First Submitted: 2023-12-14
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of resting energy expenditure (REE) in patients with incurable cancer measured with the COSMED Q-NRG+ Indirect Calorimeter with a Canopy Hood.	Throughout study completion, approximately 3 years.	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.

Secondary Outcome Measures

Name	Time	Method
Clinical factors associated with hyper- and hypometabolism	Throughout study completion, approximately 3 years.	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).

Trial Locations

Locations (1)

Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital; 🇳🇴 Trondheim, Norway