NCT06206785

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Sep 2023Dec 2027

Study Start

First participant enrolled

September 5, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

December 14, 2023

Last Update Submit

June 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical factors associated with hyper- and hypometabolism

    Throughout study completion, approximately 3 years.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital

Trondheim, 7021, Norway

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsCachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Central Study Contacts

Trude R Balstad, PhD

CONTACT

Marianne Erichsen, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 16, 2024

Study Start

September 5, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

June 6, 2025

Record last verified: 2025-06

Locations