Resting Energy Expenditure in Palliative Cancer Patients

Cancer Clinical Trial

— REPAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206785
• Other study ID #: 622545
• Status: Recruiting
• Start date: September 5, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Norwegian University of Science and Technology
• Contact: Trude R Balstad, PhD
• Phone: +4792282665
• Email: trude.r.balstad[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cancer

Locations

Country	Name	City	State
Norway	Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital, UiT The Arctic University of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   Current Research Information System in Norway