Metabolism of Lipids in Advanced Cancer

This study has been terminated.
(ethics approval not renewed by Study Group)
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00962234
First received: August 17, 2009
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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 Intervention
Lung Neoplasms
Cachexia
Other: Blood draws
Biological: Oral administration of stable isotope (deuterium)
Procedure: Metabolic rate testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Metabolism of Lipids in Advanced Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Rate of hepatic de novo lipogenesis [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of fat transport and availability [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Resting metabolic rate & fat oxidation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 12
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Lung cancer patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962234

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Vera Mazurak, PhD AHS Cancer Control Alberta
  More Information

Additional Information:
No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00962234     History of Changes
Other Study ID Numbers: CIHR PIN 111846/ethics 24906, CIHR PIN 111846
Study First Received: August 17, 2009
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Lipogenesis
Lipolysis
Phospholipids
Body Composition
Nutritional Status
Lipid Metabolism

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014