Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06206785
Other study ID # 622545
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery