Hypermetabolism in the Elderly Lung Cancer Patient (HELP)

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Carcinoma

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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hopital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured resting energy expenditure (mREE) in kilocalorie per day	Energy expenditure is measured by indirect calorimetry.	Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Paris 5 - Rene Descartes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Aging; Hypermetabolism
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LBN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No