NCT03141957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

April 28, 2017

Last Update Submit

May 4, 2017

Conditions

Keywords

AgingHypermetabolism

Outcome Measures

Primary Outcomes (1)

  • Measured resting energy expenditure (mREE) in kilocalorie per day

    Energy expenditure is measured by indirect calorimetry.

    Day 0

Secondary Outcomes (14)

  • Blood C-Reactive Protein in milligram per milliliter

    Day 0

  • Blood Interleukine-6 in picogram per milliliter

    Day 0

  • Blood Tumor Necrosis Factor alpha in picogram per milliliter

    Day 0

  • Blood Insulin in milliunit per liter

    Day 0

  • Blood ultra-sensitive Thyroid Stimulating Hormone in milliunit per liter

    Day 0

  • +9 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Non-small cell lung carcinoma

You may not qualify if:

  • Imbalanced Diabetes
  • Imbalanced dysthyroidia
  • Any chronic auto-immune or inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 5, 2017

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations