Metabolism of Lipids in Advanced Cancer

Sponsor

AHS Cancer Control Alberta (Other)

Overall Status

Terminated

CT.gov ID

NCT00962234

Collaborator

Cross Cancer Institute (Other)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Cachexia	Other: Blood draws Biological: Oral administration of stable isotope (deuterium) Procedure: Metabolic rate testing

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Metabolism of Lipids in Advanced Cancer

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Metabolism Lung cancer patients who exhibit abnormalities in lipid measures.	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 Other Names: C/D/N Isotopes, Deuterium Oxide, CAS No: 7789-20-0 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.

Arm

Intervention/Treatment

Metabolism

Lung cancer patients who exhibit abnormalities in lipid measures.

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

Other Names:

C/D/N Isotopes, Deuterium Oxide, CAS No: 7789-20-0

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.

Outcome Measures

Primary Outcome Measures

Rate of hepatic de novo lipogenesis [9 months]

Secondary Outcome Measures

Measures of fat transport and availability [9 months]
Resting metabolic rate & fat oxidation [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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