Lung NeoplasmsNCT00962234
Metabolism of Lipids in Advanced Cancer
An observational study of Lung Neoplasms and Cachexia, run by AHS Cancer Control Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Neoplasms, Cachexia
- What is being tested?
- Blood draws, Oral administration of stable isotope (deuterium) and Metabolic rate testing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients
Who may be able to join
- Low plasma phospholipids OR low plasma ratio of triglycerides to free fatty acids
- Recent weight loss
- Advanced stage lung cancer (Stage 3 or 4)
Who cannot join
- Having symptoms that may affect measures of fat metabolism (nausea, vomiting, problems swallowing, etc.)
- Taking n-3 fatty acid supplements such as fish oil
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Neoplasms, Cachexia
- Being tested
- Blood draws, Oral administration of stable isotope (deuterium), Metabolic rate testing
- Keywords
- Lipogenesis, Lipolysis, Phospholipids, Body Composition, Nutritional Status, Lipid Metabolism
- Medical subject headings
- Lung Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsOther
Up to 4 blood draws will be required, in the amount of about 10 mL each
Oral administration of stable isotope (deuterium)Biological
Also called C/D/N Isotopes, Deuterium Oxide, CAS No: 7789-20-0
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
Metabolic rate testingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Metabolism | Lung cancer patients who exhibit abnormalities in lipid measures. Receives: Other: Blood draws; Biological: Oral administration of stable isotope (deuterium); Procedure: Metabolic rate testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hepatic de novo lipogenesis
Measured: 9 months
Secondary outcomes (2)
Measures of fat transport and availability
Measured: 9 months
Resting metabolic rate & fat oxidation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: ethics approval not renewed by Study Group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Vera Mazurak, PhD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962234
- Sponsor's protocol ID
- CIHR PIN 111846/ethics 24906
- Other IDs
- CIHR PIN 111846
- Status last verified
- Apr 2012
- First submitted
- 17 Aug 2009
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism of Lipids in Advanced Cancer
- ClinicalTrials.gov ID
- NCT00962234
- Acronym / sponsor ID
- CIHR PIN 111846/ethics 24906
- Conditions
- Lung Neoplasms, Cachexia
- Keywords
- Lipogenesis, Lipolysis, Phospholipids, Body Composition, Nutritional Status, Lipid Metabolism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: ethics approval not renewed by Study Group
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolism | – | Other: Blood draws, Biological: Oral administration of stable isotope (deuterium), Procedure: Metabolic rate testingLung cancer patients who exhibit abnormalities in lipid measures. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (3 listed)
- Low plasma phospholipids OR low plasma ratio of triglycerides to free fatty acids
- Recent weight loss
- Advanced stage lung cancer (Stage 3 or 4)
Key exclusion criteria (2 listed)
- Having symptoms that may affect measures of fat metabolism (nausea, vomiting, problems swallowing, etc.)
- Taking n-3 fatty acid supplements such as fish oil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawsUp to 4 blood draws will be required, in the amount of about 10 mL each | Other | Metabolism |
| Oral administration of stable isotope (deuterium)Also: C/D/N Isotopes, Deuterium Oxide, CAS No: 7789-20-01 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 | Biological | Metabolism |
| Metabolic rate testingMetabolic 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. | Procedure or surgery | Metabolism |
Primary outcome
Rate of hepatic de novo lipogenesis
Time frame: 9 months
2 secondary outcomes
Measures of fat transport and availability
Time frame: 9 months
Resting metabolic rate & fat oxidation
Time frame: 9 months
Results and safety
The study was stopped early (reason given: ethics approval not renewed by Study Group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Mazurak, PhD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Cachexia, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: ethics approval not renewed by Study Group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hepatic de novo lipogenesis (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.