Non-small Cell Lung CarcinomaHELPNCT03141957
Hypermetabolism in the Elderly Lung Cancer Patient
An observational study of Non-small Cell Lung Carcinoma, run by University of Paris 5 - Rene Descartes at 1 site in France.
Trial summary
Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Carcinoma
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Nov 2016
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population is selected from the patients coming for their one-day pre-treatment evaluation at the oncology ward of the Cochin Hospital.
Who may be able to join
- Non-small cell lung carcinoma
Who cannot join
- Imbalanced Diabetes
- Imbalanced dysthyroidia
- Surgery within two month prior inclusion
- Any chronic auto-immune or inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.
Read the detailed description
During aging, among other physiological modifications, inactivity and insulin resistance cause a progressive muscle loss associated with a decrease in resting energy expenditure (REE). In cancer, loud inflammation background also provokes a decrease in muscle mass as well as in fat mass. However, previous studies reported an increased REE, termed hypermetabolism, probably linked to inflammation.
Data concerning response to aggression in the elderly patient is scarce and even inexistent when it comes to cancer. The investigators hypothesize that the mitochondrial dysfunction that comes with aging and that decreases the ATP rendering per unit of energy-producing nutrient oxidized increases the amount of nutrient to be consumed in order to sustain to energy needs. Therefore, in this situation, elderly patients could have a higher rate or degree of hypermetabolism than younger patients.
The primary objective of this study is to assess the effect of aging on the metabolic response to cancer assessed by resting energy expenditure measured by indirect calorimetry corrected by whole body fat free mass calculated from single slice CT imaging at the third lumbar vertebra.
The secondary objective of this study is to point out some inflammatory or endocrine determinants of these energy metabolism changes in the cancer patient.
Non-small cell lung carcinoma seems to be a relevant choice for this study because it is frequently associated with cachexia and the literature reports a high rate of hypermetabolism in this cancer.
- Conditions
- Non-small Cell Lung Carcinoma
- Keywords
- Aging, Hypermetabolism
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young patients | Patients with non-small cell lung carcinoma younger than 75y | |
| Elderly patients | Patients with non-small cell lung carcinoma aged 75 or more |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured resting energy expenditure (mREE) in kilocalorie per day
Energy expenditure is measured by indirect calorimetry.
Measured: Day 0
Secondary outcomes (14)
Blood C-Reactive Protein in milligram per milliliter
Inflammatory status
Measured: Day 0
Blood Interleukine-6 in picogram per milliliter
Inflammatory status
Measured: Day 0
Blood Tumor Necrosis Factor alpha in picogram per milliliter
Inflammatory status
Measured: Day 0
Blood Insulin in milliunit per liter
Endocrine Status - Glucose Homeostasis
Measured: Day 0
Blood ultra-sensitive Thyroid Stimulating Hormone in milliunit per liter
Endocrine Status - Thyroid Function
Measured: Day 0
Blood Insulin-like Growth Factor 1 in nanogram per liter
Endocrine Status - Somatotropic axis
Measured: Day 0
Blood Glucose in millimole per liter
Endocrine Status
Measured: Day 0
Homeostasis Model assessment of Insulin resistance
Aggregates blood Insulin and glucose level as an insulin resistance score
Measured: Day 0
Lean Body Mass in kilogram
Estimated from muscular area at the third lombular vertebra from CT-scan
Measured: Day 0
energy intake in kilocalorie per day
Estimated by a qualified dietetican
Measured: Day 0
Albumin in gram per liter
Nutritional Satus
Measured: Day 0
Transthyretin in gram per liter
Nutritional Satus
Measured: Day 0
Predicted resting energy expenditure (HB) in kilocalorie per day
REE estimated with Harris \& Benedict Formula
Measured: Day 0
Percentage of estimated energy expenditure
Percentage of HB : (mREE/HB) x 100
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study startJan 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CarcinomaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Ulmann, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141957
- Sponsor's protocol ID
- LBN001
- Acronym
- HELP
- Status last verified
- May 2017
- First submitted
- 28 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulmann G, Jouinot A, Tlemsani C, Curis E, Kousignian I, Neveux N, Durand JP, Goldwasser F, Cynober L, De Bandt JP. Lean Body Mass and Endocrine Status But Not Age Are Determinants of Resting Energy Expenditure in Patients with Non-Small Cell Lung Cancer. Ann Nutr Metab. 2019;75(4):223-230. doi: 10.1159/000504874. Epub 2019 Dec 19.
PubMed 31865308
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypermetabolism in the Elderly Lung Cancer Patient
- ClinicalTrials.gov ID
- NCT03141957
- Acronym / sponsor ID
- HELP / LBN001
- Conditions
- Non-small Cell Lung Carcinoma
- Keywords
- Aging, Hypermetabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.
Detailed description
During aging, among other physiological modifications, inactivity and insulin resistance cause a progressive muscle loss associated with a decrease in resting energy expenditure (REE). In cancer, loud inflammation background also provokes a decrease in muscle mass as well as in fat mass. However, previous studies reported an increased REE, termed hypermetabolism, probably linked to inflammation.
Data concerning response to aggression in the elderly patient is scarce and even inexistent when it comes to cancer. The investigators hypothesize that the mitochondrial dysfunction that comes with aging and that decreases the ATP rendering per unit of energy-producing nutrient oxidized increases the amount of nutrient to be consumed in order to sustain to energy needs. Therefore, in this situation, elderly patients could have a higher rate or degree of hypermetabolism than younger patients.
The primary objective of this study is to assess the effect of aging on the metabolic response to cancer assessed by resting energy expenditure measured by indirect calorimetry corrected by whole body fat free mass calculated from single slice CT imaging at the third lumbar vertebra.
The secondary objective of this study is to point out some inflammatory or endocrine determinants of these energy metabolism changes in the cancer patient.
Non-small cell lung carcinoma seems to be a relevant choice for this study because it is frequently associated with cachexia and the literature reports a high rate of hypermetabolism in this cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young patients | – | –Patients with non-small cell lung carcinoma younger than 75y |
| Elderly patients | – | –Patients with non-small cell lung carcinoma aged 75 or more |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population is selected from the patients coming for their one-day pre-treatment evaluation at the oncology ward of the Cochin Hospital.
Key inclusion criteria (1 listed)
- Non-small cell lung carcinoma
Key exclusion criteria (4 listed)
- Imbalanced Diabetes
- Imbalanced dysthyroidia
- Surgery within two month prior inclusion
- Any chronic auto-immune or inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measured resting energy expenditure (mREE) in kilocalorie per day
Time frame: Day 0
Energy expenditure is measured by indirect calorimetry.
14 secondary outcomes
Blood C-Reactive Protein in milligram per milliliter
Time frame: Day 0
Blood Interleukine-6 in picogram per milliliter
Time frame: Day 0
Blood Tumor Necrosis Factor alpha in picogram per milliliter
Time frame: Day 0
Blood Insulin in milliunit per liter
Time frame: Day 0
Blood ultra-sensitive Thyroid Stimulating Hormone in milliunit per liter
Time frame: Day 0
Blood Insulin-like Growth Factor 1 in nanogram per liter
Time frame: Day 0
Blood Glucose in millimole per liter
Time frame: Day 0
Homeostasis Model assessment of Insulin resistance
Time frame: Day 0
Lean Body Mass in kilogram
Time frame: Day 0
energy intake in kilocalorie per day
Time frame: Day 0
Albumin in gram per liter
Time frame: Day 0
Transthyretin in gram per liter
Time frame: Day 0
Predicted resting energy expenditure (HB) in kilocalorie per day
Time frame: Day 0
Percentage of estimated energy expenditure
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 31865308Ulmann G, Jouinot A, Tlemsani C, Curis E, Kousignian I, Neveux N, Durand JP, Goldwasser F, Cynober L, De Bandt JP. Lean Body Mass and Endocrine Status But Not Age Are Determinants of Resting Energy Expenditure in Patients with Non-Small Cell Lung Cancer. Ann Nutr Metab. 2019;75(4):223-230. doi: 10.1159/000504874. Epub 2019 Dec 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non-small Cell Lung Carcinoma, run by University of Paris 5 - Rene Descartes at 1 site in France.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 May 2017. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measured resting energy expenditure (mREE) in kilocalorie per day (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141957, which also lists 1 linked publication.
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 8 May 2017.