Hypermetabolism in the Elderly Lung Cancer Patient

Non-small Cell Lung Carcinoma Clinical Trial

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Official title:

Hypermetabolism in the Elderly Lung Cancer Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141957
• Other study ID #: LBN001
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: May 4, 2017
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: May 2017
• Source: University of Paris 5 - Rene Descartes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Carcinoma

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured resting energy expenditure (mREE) in kilocalorie per day	Energy expenditure is measured by indirect calorimetry.	Day 0
Secondary	Blood C-Reactive Protein in milligram per milliliter	Inflammatory status	Day 0
Secondary	Blood Interleukine-6 in picogram per milliliter	Inflammatory status	Day 0
Secondary	Blood Tumor Necrosis Factor alpha in picogram per milliliter	Inflammatory status	Day 0
Secondary	Blood Insulin in milliunit per liter	Endocrine Status - Glucose Homeostasis	Day 0
Secondary	Blood ultra-sensitive Thyroid Stimulating Hormone in milliunit per liter	Endocrine Status - Thyroid Function	Day 0
Secondary	Blood Insulin-like Growth Factor 1 in nanogram per liter	Endocrine Status - Somatotropic axis	Day 0
Secondary	Blood Glucose in millimole per liter	Endocrine Status	Day 0
Secondary	Homeostasis Model assessment of Insulin resistance	Aggregates blood Insulin and glucose level as an insulin resistance score	Day 0
Secondary	Lean Body Mass in kilogram	Estimated from muscular area at the third lombular vertebra from CT-scan	Day 0
Secondary	energy intake in kilocalorie per day	Estimated by a qualified dietetican	Day 0
Secondary	Albumin in gram per liter	Nutritional Satus	Day 0
Secondary	Transthyretin in gram per liter	Nutritional Satus	Day 0
Secondary	Predicted resting energy expenditure (HB) in kilocalorie per day	REE estimated with Harris & Benedict Formula	Day 0
Secondary	Percentage of estimated energy expenditure	Percentage of HB : (mREE/HB) x 100	Day 0