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Metabolism of Lipids in Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00962234
Recruitment Status : Terminated (ethics approval not renewed by Study Group)
First Posted : August 19, 2009
Last Update Posted : February 26, 2016
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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
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 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 : October 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort 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 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.



Primary Outcome Measures :
  1. Rate of hepatic de novo lipogenesis [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Measures of fat transport and availability [ Time Frame: 9 months ]
  2. Resting metabolic rate & fat oxidation [ Time Frame: 9 months ]

Biospecimen Retention:   Samples With DNA
Blood


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962234


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

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
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: April 2012

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

Additional relevant MeSH terms:
Cachexia
Lung Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Deuterium Oxide
Antineoplastic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs