Metabolism of Lipids in Advanced Cancer

February 24, 2016 updated by: AHS Cancer Control Alberta
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lung cancer patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of hepatic de novo lipogenesis
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measures of fat transport and availability
Time Frame: 9 months
9 months
Resting metabolic rate & fat oxidation
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

Investigators

  • Principal Investigator: Vera Mazurak, PhD, AHS Cancer Control Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (Estimate)

August 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR PIN 111846/ethics 24906
  • CIHR PIN 111846

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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