Metabolism of Lipids in Advanced Cancer

Lung Neoplasms Clinical Trial

Official title:

Metabolism of Lipids in Advanced Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00962234
• Other study ID #: CIHR PIN 111846/ethics 24906
• Secondary ID: CIHR PIN 111846
• Status: Terminated
• Phase: N/A
• First received: August 17, 2009
• Last updated: February 24, 2016
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Description:

Weight loss in cancer is the result of breakdown of fat (lipid) and muscle protein reserves. This research will explore how people with cancer use fat in their body through the use of tracers and measures in the blood. A stable isotope of hydrogen called 'deuterium' is used to trace the production of different fats by the liver. Other methods will determine how much and what types of fat are transported around the body. Body composition will be determined by CT scan and related to fat measures.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Low plasma phospholipids OR low plasma ratio of triglycerides to free fatty acids

• Recent weight loss

• Advanced stage lung cancer (Stage 3 or 4)

Exclusion Criteria:

• Having symptoms that may affect measures of fat metabolism (nausea, vomiting, problems swallowing, etc.)

• Taking n-3 fatty acid supplements such as fish oil

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cachexia
• Lung Neoplasms

Intervention

Other:
• Blood draws
Up to 4 blood draws will be required, in the amount of about 10 mL each

Biological:
• Oral administration of stable isotope (deuterium)
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

Procedure:
• Metabolic rate testing
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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hepatic de novo lipogenesis		9 months	No
Secondary	Measures of fat transport and availability		9 months	No
Secondary	Resting metabolic rate & fat oxidation		9 months	No