Clinical trial NCT03141957: Hypermetabolism in the Elderly Lung Cancer Patient
Official title: Hypermetabolism in the Elderly Lung Cancer Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Carcinoma
Keywords: Aging
Hypermetabolism
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Non-small cell lung carcinoma

Exclusion Criteria:

* Imbalanced Diabetes
* Imbalanced dysthyroidia
* Surgery within two month prior inclusion
* Any chronic auto-immune or inflammatory disease

Primary outcomes:
measure: Measured resting energy expenditure (mREE) in kilocalorie per day
timeFrame: Day 0
Secondary outcomes:
measure: Blood C-Reactive Protein in milligram per milliliter
timeFrame: Day 0
measure: Blood Interleukine-6 in picogram per milliliter
timeFrame: Day 0
measure: Blood Tumor Necrosis Factor alpha in picogram per milliliter
timeFrame: Day 0
measure: Blood Insulin in milliunit per liter
timeFrame: Day 0
measure: Blood ultra-sensitive Thyroid Stimulating Hormone in milliunit per liter
timeFrame: Day 0
measure: Blood Insulin-like Growth Factor 1 in nanogram per liter
timeFrame: Day 0
measure: Blood Glucose in millimole per liter
timeFrame: Day 0
measure: Homeostasis Model assessment of Insulin resistance
timeFrame: Day 0
measure: Lean Body Mass in kilogram
timeFrame: Day 0
measure: energy intake in kilocalorie per day
timeFrame: Day 0
measure: Albumin in gram per liter
timeFrame: Day 0
measure: Transthyretin in gram per liter
timeFrame: Day 0
measure: Predicted resting energy expenditure (HB) in kilocalorie per day
timeFrame: Day 0
measure: Percentage of estimated energy expenditure
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
Study officials:
References:
citation: 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.