Study Stopped
ethics approval not renewed by Study Group
Metabolism of Lipids in Advanced Cancer
2 other identifiers
observational
12
1 country
1
Brief Summary
The causes of failing nutrition status in advanced cancer are not well known. The way fat is moved, stored, burned or changed into other compounds may be affected and will be followed in patients using a tracer and other blood tests. The investigators hypothesize that fat loss and wasting results from low essential fatty acid availability in the body. Changes may occur in the liver that limits distribution and availability of fat to the body as an energy source or for other essential functions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFebruary 26, 2016
April 1, 2012
2 years
August 17, 2009
February 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of hepatic de novo lipogenesis
9 months
Secondary Outcomes (2)
Measures of fat transport and availability
9 months
Resting metabolic rate & fat oxidation
9 months
Study Arms (1)
Metabolism
Lung cancer patients who exhibit abnormalities in lipid measures.
Interventions
1 mg deuterium-labeled water/kg body water (loading dose), and 0.5 mg/kg body water diluted in 1 L of normal water (maintenance dose) to be consumed over the following 16 hours
Metabolic rate testing is a painless, non-invasive test that takes about 1h. A metabolic cart is used, which detects the amount of oxygen and carbon dioxide the body uses. Patients will lie down on a bed for 30 minutes with lights dimmed and soft music to help them relax. After 30 minutes, a canopy will be placed over the patient's head and shoulders for 30 minutes for the analysis of breath samples. This test will be performed only once for this study.
Eligibility Criteria
Lung cancer patients
You may qualify if:
- Low plasma phospholipids OR low plasma ratio of triglycerides to free fatty acids
- Recent weight loss
- Advanced stage lung cancer (Stage 3 or 4)
You may not qualify if:
- Having symptoms that may affect measures of fat metabolism (nausea, vomiting, problems swallowing, etc.)
- Taking n-3 fatty acid supplements such as fish oil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AHS Cancer Control Albertalead
- Cross Cancer Institutecollaborator
Study Sites (1)
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vera Mazurak, PhD
AHS Cancer Control Alberta
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 19, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 26, 2016
Record last verified: 2012-04