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OpenTrials
Completed

NCT Number: NCT03141957

Hypermetabolism in the Elderly Lung Cancer Patient

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Cochin

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measured resting energy expenditure (mREE) in kilocalorie per day

    Time frame: Day 0

    Energy expenditure is measured by indirect calorimetry.

Secondary outcomes

  1. Blood C-Reactive Protein in milligram per milliliter

    Time frame: Day 0

    Inflammatory status

  2. Blood Interleukine-6 in picogram per milliliter

    Time frame: Day 0

    Inflammatory status

  3. Blood Tumor Necrosis Factor alpha in picogram per milliliter

    Time frame: Day 0

    Inflammatory status

  4. Blood Insulin in milliunit per liter

    Time frame: Day 0

    Endocrine Status - Glucose Homeostasis

  5. Blood ultra-sensitive Thyroid Stimulating Hormone in milliunit per liter

    Time frame: Day 0

    Endocrine Status - Thyroid Function

  6. Blood Insulin-like Growth Factor 1 in nanogram per liter

    Time frame: Day 0

    Endocrine Status - Somatotropic axis

  7. Blood Glucose in millimole per liter

    Time frame: Day 0

    Endocrine Status

  8. Homeostasis Model assessment of Insulin resistance

    Time frame: Day 0

    Aggregates blood Insulin and glucose level as an insulin resistance score

  9. Lean Body Mass in kilogram

    Time frame: Day 0

    Estimated from muscular area at the third lombular vertebra from CT-scan

  10. energy intake in kilocalorie per day

    Time frame: Day 0

    Estimated by a qualified dietetican

  11. Albumin in gram per liter

    Time frame: Day 0

    Nutritional Satus

  12. Transthyretin in gram per liter

    Time frame: Day 0

    Nutritional Satus

  13. Predicted resting energy expenditure (HB) in kilocalorie per day

    Time frame: Day 0

    REE estimated with Harris & Benedict Formula

  14. Percentage of estimated energy expenditure

    Time frame: Day 0

    Percentage of HB : (mREE/HB) x 100

Sponsors and collaborators

Lead sponsor

University of Paris 5 - Rene Descartes

Other

Registry information

Acronym: HELP

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 5, 2017
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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